The past year has seen incremental victories in the neurodegenerative disease space with the approval of Amylyx’s Relyvrio, in ALS and Biogen and Eisai’s Leqembi (lecanemab) in Alzheimer’s disease. Despite these regulatory milestones, there are still hurdles to overcome, with delivery across the blood-brain barrier topping the list.
The company’s application is based on results from a late-stage study in which the drug was shown to reduce the rate of cognitive decline in patients with early Alzheimer’s by 27%, compared with a placebo.
The $26,500-per-year price tag for Eisai Co. Ltd. and Biogen Inc.’s newly approved Alzheimer’s disease drug is slightly above expectations, but should not dent demand for the promising therapy, Wall Street analysts said.
The U.S. Food and Drug Administration approved Eisai Co Ltd’s and Biogen Inc’s Alzheimer’s drug lecanemab for patients in the earliest stages of the mind-wasting disease, the agency said on Friday.
A letter published Wednesday in the NEJM links a stroke patient’s death to lecanemab. Eisai investigators respond.
The announcement comes as the company awaits the FDA’s decision for Biogen and Japanese partner Eisai Co’s Alzheimer’s drug lecanemab.
The U.S. Food and Drug Administration failed to adhere to its own guidance and internal practices during the approval process for Biogen’s Alzheimer’s drug Aduhelm, which was “rife with irregularities,” a congressional report showed on Thursday.
An influential drug pricing research group said Eisai Co. Ltd. and Biogen Inc.’s new Alzheimer’s disease treatment lecanemab should be priced lower than the drug Aduhelm that was developed by the companies.
2022 featured pivotal data that could change the landscape in non-alcoholic steatohepatitis, Alzheimer’s disease, sickle cell disease and many more indications.
A review of the latest executive moves in the pharma industry over the past several months.