Alzheimer’s disease
Biogen and Eisai have spent much of Leqembi’s launch convincing physicians and patients that it’s safe to treat Alzheimer’s disease. With patients now hitting the 18-month mark of treatment, the conversation is finally shifting to efficacy.
Leqembi’s sales in the U.S. continue to underwhelm, overshadowed by its growth in international markets.
The company, co-founded by Nobel Laureate Craig Mello, aims to push molecules for Huntington’s and a form of epilepsy into Phase I trials, with additional preclinical assets targeting Parkinson’s and Alzheimer’s.
The monthly maintenance regimen, which offers a more convenient frequency than the initially approved treatment schedule for patients with Alzheimer’s, could help with Leqembi’s thus far disappointing uptake and sales.
Vigil Neuroscience reported a strong safety profile and 50% sTREM2 reduction in an early-stage trial for VG-3927, potentially representing a new avenue for treating Alzheimer’s disease.
Computational research conducted by scientists from Washington University in St. Louis shows that GLP-1 agonists can have mental and cognitive health benefits but may also harm the kidneys and pancreas.
An OIG report zeroed in on what it said were three particularly problematic accelerated approvals: Biogen’s Aduhelm, Sarepta’s Exondys and Covis’ Makena.
JPM25 is in full swing as several pharma powerhouses—including Merck, Lilly and Amgen—detail their strategies for growth in the coming year.
The FDA accepted Biogen and Eisai’s BLA for a subcutaneous administration of the anti-amyloid antibody Monday as the partners await the regulator’s decision on a new intravenous regimen following an underwhelming launch riddled with coverage and accessibility barriers.
Among the FDA’s pending decisions for this quarter are Vertex’s non-opioid pain drug and Sanofi’s RNA interference therapy for hemophilia A and B.
PRESS RELEASES