Eisai/Biogen’s Leqembi Will See Broadened Access To Majority Of Patients

Full Approval For Alzheimer’s Triggers CMS Coverage

CMS will cover Leqembi now that the US FDA has converted Leqembi’s accelerated approval to traditional approval, giving most patients eligible for treatment access to the drug. Updated labeling puts greater emphasis on safety concerns.

Geriatric doctor consults with Alzheimer's patient
Leqembi's updated label has new language for prescribers on safety • Source: Shutterstock

Eisai Co., Ltd. and its partner Biogen, Inc. can proceed with the full commercial launch of Leqembi (lecanemab) now that the Alzheimer’s drug has received full approval from the US Food and Drug Administration, and since the Centers for Medicare and Medicaid Services (CMS) confirmed a commitment it made in June to provide Medicare coverage for anti-amyloid therapies granted full approval.

The FDA converted Leqembi’s accelerated approval to traditional approval on 6 July, effectively broadening access to the amyloid protofibril-targeting antibody...

More from New Products

More from Scrip

Pharma Gets A Compatriot At CDER With Tidmarsh Appointment To Top Spot

 

Drug manufacturers may find comfort in the appointment of former biotech CEO and entrepreneur George Tidmarsh to lead the FDA’s Center for Drug Evaluation and Research.

Alkermes To Advance Alixorexton After Positive Phase II Narcolepsy Results

 

The biotech company is planning for Phase III based on positive topline results from Vibrance-1 in narcolepsy type 1 and remains optimistic about type 2 disease.

After Gilead Deal, Hookipa Hangs Up Its Hat

 
• By 

The Austrian firm is delisting from the NASDAQ and closing down.