Biogen has informed the European Medicines Agency (EMA) that it is withdrawing its application for marketing authorisation for aducanumab for the treatement of Alzheimer’s disease The EMA had previously found on 16 December 2021 that the benefits of aducanumab did not outweigh its risks and recommended refusing marketing authorisation. Biogen then requested a re-examination. Following…
Category: Alzheimer’s Disease
Phase 2 LUMINARY Study of SAGE-718 in Patients with Mild Cognitive Impairment and Mild Dementia due to Alzheimer’s Disease
Sage Therapeutics presents promising results from LUMINARY Study Data presented during the Emerging Science Session at the American Academy of Neurology’s Annual Meeting, April 2022 The LUMINARY Study is a Phase 2, open-label study evaluating the safety, tolerability and efficacy of SAGE-718 once daily in individuals with mild cognitive impairment and mild dementia due to…
FDA Grants Accelerated Approval for Alzheimer’s Drug aducanumab
From www.fda.gov On June 8th, the US Food and Drug Administration approved Aduhelm (aducanumab) for the treatment of Alzheimer’s. Aduhelm was approved using the accelerated approval pathway, which can be used for a drug for a serious or life-threatening illness that provides a meaningful therapeutic advantage over existing treatments. Accelerated approval can be based on…
