The Alzheimer’s Association has deployed 1,000 people diagnosed with, or caring for someone with the disease, to meet with all 535 members of Congress across the United States and urge them to press Medicare for early access to a new class of drugs, beginning with lecanemab, that promise to slow the disease.
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Japanese drugmaker Eisai Co. Ltd. and its U.S. partner Biogen Inc. said on Monday that the U.S. Food and Drug Administration granted priority review for traditional approval of their Alzheimer’s treatment lecanemab.
The application to the EMA was based on results from a late-stage study that showed the drug slowed down the rate of cognitive decline in patients with early Alzheimer’s by 27%, compared with a placebo.
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 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.
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.