Tag Archive for: Aduhelm

An investigator in the Phase III trial for Biogen and Eisai’s experimental Alzheimer’s drug lecanemab is attributing a patient’s death to the drug. 

The FDA released guidelines Thursday in an attempt to clarify processes for assessing a drug candidate’s efficacy while simultaneously examining several endpoints.

Say what you will about the $158,000 price tag on Amylyx’s newly minted Relyvrio or the worthiness of the CENTAUR trial, the FDA’s approval of its third-ever ALS drug has ignited the growing momentum in the space.     

The U.S. Food and Drug Administration has agreed to review Biogen Inc.’s experimental treatment for an inherited form of amyotrophic lateral sclerosis (ALS), after the therapy failed a late-stage study but showed promise in some patients.

The agency will expedite its review of Eisai Co Ltd’s (4523.T) and Biogen Inc’s (BIIB.O) experimental Alzheimer’s drug lecanemab, with a decision due by Jan 6, 2023, the companies said on Tuesday.

Biogen indicated it has terminated an observational study of its approved Alzheimer’s drug Aduhelm (aducanumab-avwa) following its post on ClinicalTrials.gov.

Biogen and Ionis Pharmaceuticals have announced results from the Phase III VALOR trial and an open-label extension trial of the amyotrophic lateral sclerosis (ALS) hopeful tofersen. This data suggests that earlier initiation of the drug compared to delayed initiation decreased declines in clinical function, respiratory function, muscle strength and quality of life.