Neurimmune AG informed today that the U.S. Food and Drug Administration (FDA) has accepted Biogen’s Biologics License Application (BLA) and granted priority review for the approval of aducanumab as a treatment for Alzheimer’s disease. If approved, aducanumab would be the first treatment with the potential to meaningfully change the course of Alzheimer’s disease, and the first therapy to demonstrate that removing amyloid beta resulted in better clinical outcomes.
“Today’s news is an important step in the development of the first disease-modifying treatment for Alzheimer’s disease,“ said Roger Nitsch, CEO of Neurimmune. “Aducanumab is a human monoclonal antibody that removes amyloid beta in patients’ brains, resulting in meaningful effects on brain functions in patients with Alzheimer’s disease. We are welcoming the FDA’s decision to accept the BLA filing and to grant priority review for 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 together with a team of researchers at the University of Zurich and licensed it to Biogen. Aducanumab is an investigational human monoclonal antibody studied for the treatment of early Alzheimer's disease. Neurimmune has used its Reverse Translational Medicine technology to also discover 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 the vectorized expression of human antibody genes.
Contact for Media
Martin Meier-Pfister
+41 43 244 8140
media@neurimmune.com
