Tag Archive for: Alzheimer’s disease

Nine months into the U.S. launch of the first drug proven to slow the advance of Alzheimer’s, Eisai and Biogen’s Leqembi is facing an unexpected hurdle to widespread use: an entrenched belief among some doctors that treating the memory-robbing disease is futile.

The filing of a Biologics License Application for a subcutaneous version of Biogen and Eisai’s Leqembi (lecanemab) has been delayed due to procedural reasons, the companies announced Monday.

While disease-modifying therapies largely steal the spotlight in Alzheimer’s drug development, several companies are working to solve this less-discussed but disruptive facet of the illness.

The European Union’s medicines regulator has delayed it decision on Eisai and partner Biogen’s Alzheimer’s disease drug that was expected this week, the Japanese company said today.

Yesterday the agency published a revised draft guidance document, aimed at helping sponsors and pharmaceutical companies to develop therapies for Alzheimer’s disease, particularly in its early stages before the onset of overt dementia.

In a neurology update for investors, Roche touted data from a small Ib/IIa trial for trontinemab, an investigational therapy for Alzheimer’s disease which demonstrated “rapid and robust” amyloid plaque reduction.

The FDA will convene its Peripheral and Central Nervous System Drugs Advisory Committee to discuss Eli Lilly’s application for its Alzheimer’s disease antibody donanemab, the company announced today.

The company expects to reach 90% of its target for integrated delivery networks (IDNs) used to administer the drug in the U.S. in the fiscal year ending this month, its CEO stated.

Otsuka Pharmaceuticals on Monday announced that its investigational drug candidate AVP-786 fell short of its primary efficacy endpoint in a Phase III trial evaluating its effects as a treatment for agitation in Alzheimer’s disease.

During yesterday’s third-quarter fiscal year 2023 earnings report, Eisai revealed that the launch of its Biogen-partnered Alzheimer’s disease treatment Leqembi (lecanemab) has not been going according to plan, making the company’s goal of treating 10,000 patients by the end of March 2024 appear out of reach.