Neurimmune AG announced today that Biogen has submitted a Japanese New Drug Application (J-NDA) to the Ministry of Health, Labor and Welfare (MHLW) for aducanumab, an investigational therapy for Alzheimer’s disease. If approved, aducanumab would be the first treatment with the potential to effectively reduce amyloid beta in patients’ brains to meaningfully change the course of Alzheimer’s disease.
“The submission of the Japanese New Drug Application is an important milestone in our joint effort with Biogen and Eisai to make aducanumab available to patients with a diagnosis of Alzheimer’s disease worldwide,” said Roger Nitsch, CEO of Neurimmune. “If aducanumab is approved, we may step into a new era of treating Alzheimer’s disease by removing its underlying pathology.”
Japan has the highest proportion of elderly citizens of any country in the world, and aging is the greatest risk factor for developing Alzheimer’s disease with cognitive impairment and dementia as leading clinical signs. Aducanumab is now under regulatory review in Japan, Europe and the United States.
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
