Neurimmune AG announced today that the European Medicines Agency (EMA) has accepted Biogen’s marketing authorization application (MAA) for aducanumab for the treatment of Alzheimer’s disease. If approved, aducanumab would be the first treatment with the potential to meaningfully change the course of Alzheimer’s disease.
“Today’s acceptance of the MAA by the European Medicines Agency marks an important step in our joint effort with Biogen and Eisai to make aducanumab broadly available to patients with a diagnosis of Alzheimer’s disease in Europe,” said Roger Nitsch, CEO of Neurimmune. “If approved, aducanumab could be the first treatment that effectively reduces the neuropathology in patients’ brains, resulting in slowed progression of clinical decline associated with the disease.”
In Europe, more than one fifth of the population is older than 65 years, and aging is the greatest risk factor for developing Alzheimer’s disease with cognitive impairment and dementia as leading clinical signs. After the U.S. Food and Drug Administration, the EMA is the second regulatory authority to accept Biogen’s application for regulatory review of aducanumab.
Neurimmune discovered aducanumab together with a team of researchers at the University of Zurich. In 2007 Neurimmune and Biogen entered into a collaborative development and license agreement for aducanumab's development and commercialization.
About Neurimmune
Neurimmune is a biopharmaceutical company translating human immune memory into transformative antibody therapeutics. Neurimmune develops drug candidates for CNS and related protein aggregation diseases including Alzheimer’s disease, Parkinson’s disease, amyotrophic lateral sclerosis, frontotemporal dementia, dementia with Lewy bodies and ATTR cardiomyopathy. Neurimmune discovered aducanumab, a human monoclonal antibody targeting aggregated amyloid beta, together with a team of researchers at the University of Zurich and licensed it to Biogen. With its Reverse Translational Medicine technology, Neurimmune also discovered cinpanemab for Parkinson's disease, the anti-tau antibody BIIB076 for Alzheimer's disease, the anti-miSOD1 antibody AP-101 for ALS and the anti-ATTR antibody NI006 for ATTR cardiomyopathy, programs being currently evaluated in clinical trials. Neurimmune has three additional antibody programs in preclinical development, and has recently expanded the spectrum of its treatment modalities by adding a small molecule program and programs involving vectorized expression of human antibody genes.
Contact for Media
Martin Meier-Pfister
+41 43 244 8140
media@neurimmune.com
