BIIB - Biogen Eisai's Alzheimer's drug Leqembi gets FDA priority review for traditional approval

2023-03-06 04:34:16 ET

The U.S. Food and Drug Administration (FDA) granted priority review to Biogen's ( NASDAQ: BIIB ) application seeking traditional approval of Alzheimer's disease (AD) therapy Leqembi (lecanemab) from its current status of accelerated approval.

At the start of this year, the FDA granted accelerated approval to Biogen and Eisai's ( OTCPK:ESALF ) ( OTCPK:ESAIY ) lecanemab to treat patients with the mild cognitive impairment or mild dementia stage of disease and confirmed presence of A? pathology.

The accelerated approval was based on data from a phase 2 trial.

The FDA accepted Biogen's supplemental biologics license application (sBLA) for Leqembi (lecanemab-irmb) 100 mg/mL injection for intravenous use. The agency is expected to make a decision by July 6.

Under priority review, the FDA's goal is to take action within six months, compared to 10 months under standard review.

The company noted that the sBLA contains confirmatory data from a phase 3 study, dubbed Clarity AD, which will be evaluated by FDA to decide if it will convert the accelerated approval of the drug to a traditional approval.

Biogen said that FDA is currently planning to hold an advisory committee to discuss the application but has not provided a date yet.

Lecanemab is also under priority review in China and Japan and under revie in the EU .

Eisai acts as the lead for lecanemab development and regulatory filings globally with both Eisai and Biogen co-commercializing and co-promoting the drug, according to the company.

Meanwhile, BioArctic ( OTCPK:BRCTF ) has a right to commercialize lecanemab in the Nordic under certain conditions.

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