Category Archives: Haematology

Stroke prevention drugs may help reduce dementia risk for atrial fibrillation patients

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Patients with atrial fibrillation could reduce the risk of dementia by taking stroke prevention medications, according to recommendations published online in EP Europace, a European Society of Cardiology journal, and presented at EHRA 2018.

The international consensus document was also published in HeartRhythm, the official journal of the Heart Rhythm Society (HRS), and Journal of Arrhythmia, the official journal of the Japanese Heart Rhythm Society (JHRS) and the Asia Pacific Heart Rhythm Society (APHRS).

The expert consensus statement on arrhythmias and cognitive function was developed by the EHRA, a branch of the ESC; the HRS; the APHRS; and the Latin American Heart Rhythm Society (LAHRS).

Heart rhythm disorders (arrhythmias), as well as some procedures undertaken to treat them, can increase the risk of cognitive decline and dementia. The international consensus document was written for doctors specialising in arrhythmias and aims to raise awareness of the risks of cognitive impairment and dementia and how to reduce them.

The document states that atrial fibrillation is associated with a higher risk for cognitive impairment and dementia, even in the absence of apparent stroke. This may be because atrial fibrillation is linked with a more than two-fold risk of silent strokes. The accumulation of silent strokes and the associated brain injuries over time may contribute to cognitive impairment.

Stroke prevention with oral anticoagulant drugs is the main priority in the management of patients with atrial fibrillation. The consensus document says that oral anticoagulation may reduce the risk of dementia.

Adopting a healthy lifestyle may also reduce the risk of cognitive decline in patients with atrial fibrillation. This includes not smoking and preventing or controlling hypertension, obesity, diabetes, and sleep apnoea.

“Patients with atrial fibrillation may be able to reduce their risk of cognitive impairment and dementia by taking their oral anticoagulation medication and having a healthy lifestyle,” said Dr Nikolaos Dagres, lead author and consultant, Department of Electrophysiology, Heart Centre Leipzig, Germany.

The document also reviews the association between other arrhythmias and cognitive dysfunction, including post-cardiac arrest, in patients with cardiac implantable devices such as implantable cardioverter defibrillators (ICDs) and pacemakers, and ablation procedures.

Treatment of atrial fibrillation with catheter ablation can itself lead to silent strokes and cognitive impairment. To reduce the risk, physicians should follow recommendations for performing ablation and for the management of patients before and after the procedure.

The consensus document notes that physicians may suspect cognitive impairment if a patient’s appearance or behaviour changes — for example, if appointments are missed. Family members should be asked for collateral information. If suspicions are confirmed, the consensus document recommends tools to conduct an objective assessment of cognitive function.

The paper highlights gaps in knowledge and areas for further research. These include, for instance, how to identify atrial fibrillation patients at increased risk of cognitive impairment and dementia, the effect of rhythm control on cognitive function, and the impact of cardiac resynchronisation therapy (CRT) on cognitive function.

SOURCE: www.hospitalhealthcare.com/editors-pick

How thalidomide is effective against cerebral infarction

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Scientists reveal that this dangerous drug could suppress nerve cell death.

Notoriously remembered as a major pharmaceutical scandal approximately 60 years ago, thalidomide caused severe birth defects when many pregnant women took the drug as a remedy for their morning sickness.

In recent years, however, thalidomide and its derivatives have been widely used to treat haematologic malignancies such as multiple myeloma.

Evidence also suggests that thalidomide has a neuroprotective effect, reducing both oxidative stress and inflammatory response, but the exact molecular mechanisms of thalidomide on the brain were unknown.

To investigate, scientists at Waseda University and Tokyo University of Pharmacy and Life Sciences studied thalidomide’s target protein, cereblon (CRBN), and its binding protein, AMP-activated protein kinase (AMPK), which plays an important role in maintaining intracellular energy homeostasis in the brain.

Through their study, they revealed that thalidomide inhibits the activity of AMPK via CRBN under oxidative stress and suppresses nerve cell death.

“We hope that our findings will help with the development of new and safer thalidomide derivatives,” says Naoya Sawamura, Associate Professor of Neuropharmacology at Waseda University and leading author of this study, “to better treat diseases such as cerebral infarction, a type of stroke, which is a major cause of death worldwide.”

Specifically, Sawamura’s research group used cerebral ischaemia model rats of the cerebral artery occlusion/reperfusion (MCAO/R) to examine the effect of thalidomide on infarct lesions caused by cerebral ischaemia and related intracellular signals.

After performing qualitative analysis and assessments on the rats’ physical movements, they found that thalidomide treatment significantly decreased the infarct volume and neurological deficits in MCAO/R model rats, and that AMPK was the key signalling protein in the mechanism through additional experiments.

Moreover, to determine the molecular mechanisms of the effect of thalidomide on neuronal death, they used oxidative stress-induced neuronal cells, which were induced by administration of H2O2, as cerebral ischaemia model cells.

“In these cells, we found that the AMPK-CRBN interaction weakened and phosphorylation of AMPK enhanced, but thalidomide treatment restored the AMPK-CRBN interaction and suppressed phosphorylation of AMPK,” explains Sawamura.

“What this implies is that thalidomide regulates AMPK-CRBN interactions in cells under ischaemic conditions, meaning, it can suppress nerve cell death.”

Further study is needed to identify effective thalidomide derivatives with fewer side-effects, as well as more stability because they undergo hydrolysis spontaneously and rapidly in aqueous solutions.

Nevertheless, Sawamura is excited about the future possibilities of this study.

“Our attention is now on the functions of CRBN as a stress response molecule. The suppression of nerve cell death by thalidomide perhaps occurs because CRBN’s function as a stress molecule is somehow enhanced.”

“We want to elucidate the response of cereblons in ageing and stress models to see if decline in the CRBN function could be a biomarker for ageing and stress.”

SOURCE: www.manufacturingchemist.com/news

Magnetic nanoparticles prevent internal bleeding

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Scientists have found a way to effectively stop internal bleeding by magnetically-driven nanoparticles containing thrombin.

Scientists have found a way to effectively stop internal bleeding by magnetically-driven nanoparticles containing thrombin. A drug based on these nanoparticles can be injected intravenously and delivered straight to the site of a vascular injury. It can accelerate local clot formation and reduce overall blood loss by 15 times. The nanoparticles are not toxic to humans and can potentially be used for safe treatment.

In a new study, scientists from ITMO University suggested using magnet-driven nanoparticles to solve this problem. The particles consist of two key components. The first is thrombin, an enzyme responsible for blood clotting. It interacts with the protein called fibrinogen and triggers clot formation in order to block the damaged vessel. The thrombin is wrapped into a special porous matrix made of magnetite. This mineral is the second main ingredient and allows for precise control of the movement of particles inside the body using an external magnetic field.

Magnetic nanoparticles with thrombin have low activity and do not cause blood clotting if they are evenly distributed in blood vessels. Therefore it is possible to inject a solution of particles intravenously and localise them where needed using a magnet. When the patient receives an extra portion of fibrinogen, thrombin particles around the site of injury interact with it and the bleeding stops faster.

“We tested the nanoparticles’ efficiency on human blood plasma samples and a special vessel model,” says Andrey Drozdov, member of SCAMT Laboratory at ITMO University. “After the first experiments with plasma, we found out that thrombin in our nanoparticles is less active compared to its free variant. Yet we went on with the tests and ran additional experiments on a model of the bloodstream. We were able to observe how nanoparticles behave when the vessel is damaged. It turned out that magnetic localisation compensates for lower activity. Nanoparticles reduce the clotting time by 6.5 times and can reduce total blood loss by 15 times.”

“Synthesising these nanoparticles is not easy,” said the head of the laboratory Vladimir Vinogradov. “It is important to keep their size down to 200 nanometers; otherwise they will not be suitable for injection. In addition, mild synthesis conditions are required so that the thrombin molecule does not break down and lose its activity completely. Finally, we could only use biocompatible components. We checked the toxicity of our particles with human cells and made sure they are completely safe even during prolonged exposure.”

This work is part of a larger project aiming to create hybrid nanomaterial-based hemostatic drugs. Scientists are currently planning to test the drug based on the obtained material on animal models and, in case of success, run clinical trials. Researchers hope to create a nanoparticle-based hemostasis system that will be able to quickly and efficiently stop internal bleeding.

The results were published in Scientific Reports.

SOURCE: www.europeanpharmaceuticalreview.com/news/73444

Diabetes tablet passes Phase III clinical trial

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As rates of diabetes continue to rise, the hunt for new drugs to tackle the metabolic disease is imperative.

In 2014 there were an estimated 422 million people with diabetes, compared to just 108 million in 1980.

Although there are a range of treatment options available for type 2 diabetes, many target the symptoms rather than the root cause and may have adverse side effects. A further difficulty is the close connection between diabetes and obesity, which is causing cases to increase.

Novo Nordisk’s semaglutide however permanently lowers blood glucose levels by increasing insulin production and could also treat obesity, a major underlying cause of diabetes. A recent study showed that the drug controls appetite and food cravings and could therefore generate significant weight loss.

First developed in 2012, an injectable version of semaglutide is already approved for use in the US. Now, an oral version of the drug has now passed its first Phase III clinical trial.

Semaglutide works by mimicking the action of a hormone (GLP-1) which increases insulin secretion. It can be taken orally once daily and in this 6-month trial was delivered in 3, 6 and 14 mg doses to over 700 people with type 2 diabetes.

The drug showed significant reductions in long-term blood glucose levels compared to placebo at all doses, while the highest dose also led to significant weight loss. People treated with 14mg semaglutide experienced a weight loss of over 4 kg on average.

The drug was also safe and well tolerated, causing only nausea, which reduced over time. Chief Science Officer of Novo Mads Krogsgaard Thomsen said he was encouraged by the results of the trial, adding “[The results] confirm the unprecedented oral efficacy of semaglutide that was reported in the phase 2 clinical trial in type 2 diabetes”.

There are nine additional trials running for semaglutide with over 9000 participants, results for which will be provided later this year. Novo Nordisk plan to apply for regulatory approval for the drug in 2019.

SOURCE: www.hospitalpharmacyeurope.com/editors-pick

Gilead takes ‘HIV eradication’ combo into clinic

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Gilead has become a victim of its own success in hepatitis C, as it has pioneered a series of blockbuster combination drugs that are eradicating the disease, but are depleting the revenue-creating pool of infected patients.

Faced with pressure from competitors such as Merck & Co in hepatitis C, the company is now turning back to its old stomping ground – HIV, for which it has developed an arsenal of drugs that can stay the disease’s progression into full-blown AIDS.

Unlike hepatitis C, HIV is currently incurable, as drugs from Gilead and competitors like GlaxoSmithKline and Pfizer can only suppress it so that infected people can live much longer lives than in the past.

HIV creates a latent reserve within a patient’s body, lying dormant within infected CD4 cells, which can become activated and lead to the disease progressing into AIDS.

Only by tackling this reserve of infected, but dormant, T-cells can the disease be cured – and scientists have been trying for years to find ways to do this.

Gilead thinks it may have found a solution to the complex problem of tackling the infected dormant T-cells so that patients can control the disease without need for drugs.

Data from a trial in rhesus monkeys infected with simian-human immunodeficiency virus (SHIV) show that an oral toll-like receptor 7 (TLR7) agonist antiviral drug, and a broadly neutralising antibody (bNAb) could be an effective HIV eradication strategy for tackling this latent reserve.

Data from a subset of SHIV infected monkeys on suppressive antiretroviral therapy (ART) demonstrated a combination of a TLR7 called GS-9620, and a bNAb called PGT121, resulted in viral suppression after ART therapy stopped.

In the proof-of-concept study, 45% – five out out of 11 – of animals receiving both GS-9620 and PGT121 did not demonstrate viral rebound for at least 168 days after stopping ART. The other six animals rebounded but then began re-suppressing the virus without ART.

The data published at the Conference on Retroviruses and Opportunistic Infections showed that in a placebo arm 11 out 11 animals rebounded, nine out of 11 treated with only PGT121 rebounded and 10 out of 11 treated with GS-9620 rebounded.

Gilead is calling the combination therapy an “HIV eradication strategy” and will test it in phase 1 trials, in people who are HIV suppressed on approved ART therapies.

Gilead’s chief scientific officer, Norbert Bischofberger, said: “GS-9620 is currently in a phase 1b dose-escalation study in ART-suppressed people living with HIV and we have advanced GS-9722, a derivative of PGT121, into phase 1 testing.”

Gilead licensed in PGT121 from Theraclone Sciences under an agreement signed in 2014, although details of the deal were not disclosed at the time.

It was part of a portfolio of broadly neutralising antibodies discovered in collaboration with the International AIDS Vaccine Initiative and The Scripps Research Institute, Florida.

SOURCE: www.pharmaphorum.com/news

Priority review for Shire’s HAE drug

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US regulators are undertaking a speedy review of Shire’s lanadelumab (SHP643) for the prevention of angioedema attacks in patients 12 years and older with hereditary angioedema (HAE).

HAE is a rare, genetic disorder that causes debilitating, painful and sometimes life-threatening swelling in the body.

Shire’s application for lanadelumab, an investigational fully human monoclonal antibody that specifically binds and inhibits plasma kallikrein, is supported by data from four clinical trials.

Data from the pivotal Phase III HELP study showed that subcutaneous administration of 300mg lanadelumab once every two weeks resulted in an 87 percent reduction in the mean frequency of HAE attacks.

In addition, an exploratory endpoint, which will require further confirmatory studies, showed that during the steady state stage of the trial (day 70-182) a 91 percent attack reduction was achieved with eight out of 10 patients reaching an attack free state.

In this study, no treatment-related serious adverse events or deaths were reported, the most common side effecting observed being injection site pain (29.3 percent placebo vs. 42.9 percent across lanadelumab arms).

“Physicians as well as patients in the HAE community are excited to see lanadelumab moving forward for FDA review because there is now the real possibility of having a new way to prevent HAE attacks,” said Aleena Banerji, Massachusetts General Hospital, Boston, MA, and clinical trial investigator.

The US Food and Drug Administration has granted the application a priority review, signaling its belief that the drug has the potential to provide a significant treatment benefit to patients. As such, the regulator’s assessment should be completed within eight months as opposed to 12 months, meaning that a decision is due by August 26.

SOURCE: www.pharmatimes.com/news

Largest clinical trial ever conducted in postpartum haemorrhage completed

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Ferring Pharmaceuticals and MSD, through its MSD for Mothersinitiative, has announced the completion of CHAMPION (Carbetocin Haemorrhage Prevention), a global clinical trial conducted by the Human Reproduction Program (HRP) at the World Health Organization (WHO).

CHAMPION is investigating whether Ferring’s proprietary and heat-stable carbetocin could offer a new solution to prevent excessive bleeding after childbirth (postpartum haemorrhage or PPH).2,3Involving nearly 30,000 women in 10 countries, it is the largest clinical trial ever conducted in PPH.2,3

Each year, 14 million mothers are affected by PPH.1 As the leading direct cause of maternal mortality, 480,000 mothers died from PPH between 2003-09.1 Even when women survive, PPH can result in the need for serious medical interventions, including surgical removal of the uterus (hysterectomy) as well as blood transfusions to address severe anaemia.2 By preventing PPH from ever occurring, heat-stable carbetocin has the potential to both save lives and avoid severe, dangerous and costly long-term side effects.

Despite progress towards the UN Sustainable Development Goal of reducing maternal mortality, every single day women across the world are dying unnecessarily from childbirth complications such as PPH. Timely administration of effective medicines can avoid the maternal deaths that occur due to excessive bleeding after childbirth,”3 said Mariana Widmer, Technical Officer, Maternal and Perinatal Health, WHO. “If the results of the trial for heat-stable carbetocin are favourable, this collaboration between private life sciences and the global public health community could help save women’s lives worldwide.”

The CHAMPION trial compares the effectiveness and safety of Ferring’s heat-stable carbetocin versus the current standard of care, oxytocin, for preventing PPH after vaginal birth.2,3 Heat-stable carbetocin could  address a significant limitation associated with oxytocin – the need for refrigeration during shipping and storage to prevent degradation in temperatures above 8°C.3,4 Heat-stable carbetocin may remain active long-term in hot and humid climates,3and could potentially reduce the incidence of PPH in areas where cold storage is difficult to achieve and maintain,3,4 and where 99% of maternal deaths due to PPH currently occur.4

Using our established expertise in Reproductive Medicine and Women’s Health, we strive to find innovative treatments that will help to dramatically reduce the number of mothers dying as a result of childbirth,” said Professor Klaus Dugi, Chief Medical Officer, Ferring Pharmaceuticals. “Our heat-stable carbetocin is just one example of this research effort and forms part of our ongoing commitment to safeguarding the health of families worldwide. We are looking forward to seeing the results from the CHAMPION trial and hope that the learnings will usher in a new era in the prevention of PPH.”

If the results of the CHAMPION trial are favourable, Ferring will seek registration of heat-stable carbetocin on a broad basis around the world. If approved, Ferring would manufacture the product and it would be provided to the public sector of low- and lower-middle-income countries at an affordable and sustainable access price. Results from the trial are expected to be presented and published during the second half of 2018.

The CHAMPION trial has the potential to change the paradigm in how we save more mothers from dying during childbirth,” said Julie L Gerberding, MD, MPH, Executive Vice President & Chief Patient Officer, Strategic Communications, Global Public Policy and Population Health at MSD. “Along with our partners, we recognized that heat-stable carbetocin could be a transformative solution to preventing PPH, which is the number one cause of maternal mortality.  Through MSD for Mothers, we provided our company’s scientific expertise and financial resources to prove the concept and ultimately make a sustainable impact on the health of mothers, families and communities.”

References

  1. Say L. et al. Global causes of maternal death: a WHO systematic analysis. Lancet Glob Health. 2014 Jun;2(6):e323-33.
  2. Australian New Zealand Clinical Trial Registry. Available at: https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=366743 Last accessed: January 2018.
  3. Widmer M. et al. Room temperature stable carbetocin for the prevention of postpartum haemorrhage during the third stage of labour in women delivering vaginally: study protocol for a randomized controlled trial. Trials. 2016;17(1):143. doi: 10.1186/s13063-016-1271-y.
  4. World Health Organization. Priority diseases and reasons for inclusion. Postpartum haemorrhage. Available at: http://www.who.int/medicines/areas/priority_medicines/Ch6_16PPH.pdfLast accessed: January 2018.

SOURCE: www.hospitalpharmacyeurope.com/editors-pick

Microsoft transforms diagnosis with AI systems

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The AI system aims to quicken the process of finding illnesses from blood tests.

Diagnosing patients just got a lot easier thanks to a Microsoft partnership with a biotech company that uses AI to check for multiple illnesses.

Taking the next step with technology in the healthcare sector, Microsoft has partnered with biotechnology company Adaptive to create a method for smarter blood tests using AI. The aim of using the technology is to check for hundreds of diseases at one given time, as a universal diagnostic tool.

The use of AI could drastically reduce the amount of time it takes for patients to be diagnosed, by having all types of cases catered for at one point, as well as putting patients through just one trawl of tests instead of multiple. In turn, the technology benefits doctors by saving them the job of carrying out multiple tests, when AI can do it in one swift move.

“We believe deeply in the potential for this partnership with Adaptive and have made a substantial financial investment in the company. We believe deeply in the potential for this partnership with Adaptive and have made a substantial financial investment in the company. With Microsoft’s help, adaptive biotechnologies will attempt to map the genetics of the human immune system or immunome,” Peter Lee, Corporate Vice President, AI and Research at Microsoft said.

Additionally, doctors hope that by checking for more than one disease at once will help with treatments by allowing doctors to look at correlations between different disease states and finding a better cure to target more than one illness.

The system will work by using AI to decode a patient’s immune system, come up with a diagnosis based on past trends and then treat disease with the best medication according to the system.

Adaptive Biotechnologies said to start with the two companies will focus on identifying diseases that are normally diagnosed at a later stage, such as pancreatic and ovarian cancer, and the AI system will help to identify these conditions much more easily and quickly in the future.

“Some conditions, like cancer or autoimmune disorders, can be difficult to diagnose,” said Chad Robbins, co-founder and chief executive officer of Adaptive Biotechnologies. “But this universal map of the immune system will enable earlier and more accurate diagnosis of disease.”

The partnership between the two companies is set to be discussed in further detail at the JP Morgan Healthcare Conference in San Francisco on Wednesday 10th January.

SOURCE: www.cbronline.com/news

Sanofi and Alnylam enter into RNAi therapeutics rare disease alliance

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Sanofi and Alnylam Pharmaceuticals, announced a strategic restructuring of their RNAi therapeutics alliance to optimise development and commercialisation of certain products for the treatment of rare genetic diseases.

Sanofi will obtain global development and commercialisation rights to fitusiran, an investigational RNAi therapeutic, currently in development for the treatment of people with hemophilia A and B.

Global commercialisation of fitusiran, upon approval, will be done by Sanofi Genzyme, the specialty care global business unit of Sanofi. Alnylam will receive royalties based on net sales of fitusiran products.

Alnylam will obtain global development and commercialisation rights to its investigational RNAi therapeutics programmes for the treatment of ATTR amyloidosis, including patisiran and ALN-TTRsc02. Sanofi will receive royalties based on net sales of these ATTR amyloidosis products.

With respect to other products falling under the RNAi therapeutics alliance, the material terms of the 2014 Alnylam-Sanofi Genzyme alliance remain unchanged.

“The restructured alliance reflects Sanofi Genzyme’s sustained interest in the strong potential of Alnylam’s portfolio of genetic medicines. The new structure simplifies operations, providing both parties the agility needed to make these medicines available to patients as quickly as possible once approved,” said Bill Sibold, Executive VP and Head of Sanofi Genzyme.

“This restructuring will enable both parties to maximise the value of each asset and allows us to maintain shared economics across the alliance programme.”

Fitusiran complements Sanofi Genzyme’s rare haematology portfolio and creates a focus on bringing an innovative product to market globally, upon approval, for people living with haemophilia, one of the most common rare diseases.

“This strategic restructuring enables streamlined development and an optimised approach to bringing innovative medicines to patients with ATTR amyloidosis and haemophilia around the world, maximising the commercial opportunities for these programmes,” said Dr John Maraganore, CEO of Alnylam.

“For Alnylam, this provides strategic clarity and operational alignment with regard to the development and commercialisation of patisiran and ALN-TTRsc02. This will allow us to develop both products in a comprehensive manner, potentially addressing the full spectrum of transthyretin mediated amyloidosis disease treatment and prevention. At the same time, we will continue to support and benefit — via royalties — from the fitusiran opportunity through Sanofi’s significant development and commercial leadership.”

This restructuring provides Alnylam with the opportunity to consolidate its ATTR amyloidosis business to maximise its value, and the opportunity for near-term acceleration of product revenue growth based on newly obtained rights to commercialise patisiran around the world, once approved.

In addition, it enables Alnylam to build a global presence and commercial infrastructure that can be leveraged for ALN-TTRsc02 and additional programmes, including givosiran, an investigational RNAi therapeutic for the treatment of acute hepatic porphyrias and cemdisiran, an investigational RNAi therapeutic for the treatment of complement-mediated diseases — where Alnylam has retained global ownership.

SOURCE: www.manufacturingchemist.com/news

AZ gets US green light for new Bydureon formulation

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AstraZeneca’s newly formulated Bydureon BCise (exenatide extended-release) has received US approval from the Food and Drug Administration (FDA) for adults with type 2 diabetes whose blood sugar remains uncontrolled on one or more oral medicines.

The once-weekly, single-dose auto injector device is an improved version of AZ’s Bydureon – which the British group acquired from Bristol Myers Squibb back in 2013 – and originally required a six-step preparation and administration process.

However, AZ’s latest version of the product is said to “help enhance the patient experience” and although not a weight management medicine, the product has “an added benefit” of weight reduction.

Ruud Dobber, president, AstraZeneca US, said: “With the approval of Bydureon BCise, we’re now introducing a new formulation in an improved, easy-to-use device.

“We know that physicians have established longstanding confidence in the significant HbA1c reduction Bydureon provides their patients to help achieve consistent control, with the added benefit of weight loss.”

Set across two clinical trials, patients on Bydureon BCise saw average glycated haemoglobin (HbA1c) reductions of up to 1.4% and average weight loss reductions of up to 3.1 pounds when the injectable was used as monotherapy or as an add-on.

The new formulation also has a continuous-release microsphere delivery system designed to provide consistent therapeutic levels of the active ingredient exenatide, which is said to help patients reach and maintain a steady state.

Bydureon BCise will be available for patients in the US in the first quarter of 2018 and AZ have filed an application to the European Medicines Agency for approval within the EU.

SOURCE: www.pmlive.com/pharma_news