In 2020, Biogen launched a bold 20-year, $250 million initiative to address the deeply interrelated issues of climate, health, and equity. Biogen is also commercializing biosimilars and focusing on advancing the industry’s most diversified pipeline in neuroscience that will transform the standard of care for patients in several areas of high unmet need. Today, Biogen has the leading portfolio of medicines to treat multiple sclerosis, has introduced the first approved treatment for spinal muscular atrophy, and is providing the first and only approved treatment to address a defining pathology of Alzheimer’s disease. One of the world’s first global biotechnology companies, Biogen was founded in 1978 by Charles Weissmann, Heinz Schaller, Sir Kenneth Murray, and Nobel Prize winners Walter Gilbert and Phillip Sharp.
#MASS EFFECT 3 ARIA FULL#
Please click here for US full Prescribing Information, including Medication Guide, for ADUHELM.Īs pioneers in neuroscience, Biogen discovers, develops, and delivers worldwide innovative therapies for people living with serious neurological diseases as well as related therapeutic adjacencies. are collaborating on the global co-development and co-promotion of aducanumab. Patients should call their healthcare provider for medical advice about side effects.Īs of October 2017, Biogen and Eisai Co., Ltd. The most common side effects of ADUHELM include: swelling in areas of the brain, with or without small spots of bleeding in the brain or on the surface of the brain (ARIA) headache and fall. ADUHELM can also cause serious allergic reactions. The patient’s healthcare provider will do magnetic resonance imaging (MRI) scans before and during treatment with ADUHELM to check for ARIA. Although most people do not have symptoms, some people may have symptoms such as: headache, confusion, dizziness, vision changes and nausea. ARIA is a common side effect that does not usually cause any symptoms but can be serious. The accelerated approval of ADUHELM in the United States has been granted based on data from clinical trials showing the effect of ADUHELM on reducing amyloid beta plaques, a surrogate biomarker that is reasonably likely to predict clinical benefit, in this case a reduction in clinical decline.ĪDUHELM can cause serious side effects including: Amyloid Related Imaging Abnormalities or “ARIA”. The accumulation of amyloid beta plaques in the brain is a defining pathophysiological feature of Alzheimer’s disease.
#MASS EFFECT 3 ARIA VERIFICATION#
Continued approval for this indication may be contingent upon verification of clinical benefit in confirmatory trial(s).Īducanumab-avwa is a monoclonal antibody directed against amyloid beta. This indication is approved under accelerated approval based on reduction in amyloid beta plaques observed in patients treated with ADUHELM. There are no safety or effectiveness data on initiating treatment at earlier or later stages of the disease than were studied. Treatment with ADUHELM should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in clinical trials.
“While we are disappointed with the trend vote, we strongly believe in the strength of our data and that aducanumab has the potential to make a positive and meaningful difference for people and families affected by Alzheimer’s disease,” said Priya Singhal, M.D., M.P.H., Head of Global Safety & Regulatory Sciences and interim Head of Research & Development at Biogen.Īt the recent Clinical Trials on Alzheimer’s Disease conference (CTAD), Biogen announced new Phase 3 findings that provide further evidence of aducanumab’s effect on lowering amyloid beta plaque and downstream tau pathology, the two defining pathologies of Alzheimer’s disease.Ībout ADUHELM ™ (aducanumab-avwa) injection 100 mg/mL solutionĪDUHELM is indicated for the treatment of Alzheimer’s disease in the United States. Biogen will continue to engage with the EMA and CHMP as it considers next steps towards the goal of providing access to aducanumab to patients in Europe. The CHMP is expected to adopt a formal opinion on the Marketing Authorization Application at its December meeting (December 13-16, 2021).
#MASS EFFECT 3 ARIA UPDATE#
(Tokyo, Japan) announced today an update on the ongoing review of the Marketing Authorization Application for aducanumab 100 mg/mL concentrate solution for infusion for the treatment of Alzheimer’s disease by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA).įollowing an oral explanation held at the November meeting of the CHMP, Biogen received a negative trend vote on the aducanumab Marketing Authorization Application.