The U.S. Food and Drug Administration (FDA) has given the green light for monthly dosing of an Alzheimer’s drug made by Japan’s Eisai (ESALF) and partner Biogen (BIIB), in move that could improve uptake of the treatment.
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In a statement on Sunday, the companies said the regulator had approved four-weekly maintenance dosing of the Leqembi drug, which is used for the treatment of Alzheimer’s disease in patients with mild cognitive impairment or mild dementia stage of disease.
The drug won approval in 2023, but sales growth has been limited as it requires regular MRIs and screenings.
However, the companies said maintenance dosing once every four weeks may be easier for patients and care partners to continue treatment than the current fortnightly regime.
BIIB Approvals
Last week, the FDA and the European Medicines Agency (EMA) validated Biiogen’s application for a higher dose regimen of nusinersen, marketed as Spinraza, used in the treatment of spinal muscular atrophy (SMA).
“This milestone reflects our steadfast commitment to advance treatment options for individuals with SMA, and we expect that this higher dose regimen will offer meaningful benefits to patients and their families,” said Stephanie Fradette, Head of the Neuromuscular Development Unit at Biogen.
According to Thomas Crawford, co-director of the Muscular Dystrophy Association Clinic at Johns Hopkins Medicine, the higher dose regimen can enable “meaningful clinical benefits” while maintaining a safety profile “broadly consistent” with the approved small dose regimen.
Is BIIB a Good Stock to Buy?
Overall, Wall Street has a Moderate Buy consensus rating on BIIB, based on 11 Buys and 14 Holds. After a 40% decline in the stock over the last year, the average BIIB price target of $222.40 implies about 52% upside.
