FDA Assigns Goal Date for Maintenance Dosing of Leqembi

The FDA has accepted Eisai’s supplemental biologics license application (sBLA) for monthly Leqembi (lecanemab-irmb) intravenous (IV) maintenance dosing and assigned Prescription Drug User Fee Act (PDUFA) action date of Jan. 25, 2025.

Alzheimer’s disease is a progressive disease caused by toxic amyloid proteins, and is the most common type of dementia, according to the Centers for Disease Control and Prevention. In 2020, about 5.8 million Americans were living with Alzheimer’s disease, and this is number is projected to increase to 14 million by 2060.

Leqembi is indicated to treat patients with Alzheimer's disease (AD) in patients with mild cognitive impairment or mild dementia stage of disease. Leqembi has been on the market since January 2023 when it received an accelerated approval. It received traditional approval in July 2023, and has a list price of $26,500 a year.

Eisai serves as the lead for Leqembi’s development and regulatory submissions globally with both Eisai and Biogen co-commercializing and co-promoting the product.

The sBLA is based on modeling of observed data from the phase 2 study (Study 201) and its open-label extension (OLE) as well as the Clarity AD study (Study 301) and its OLE study.

Related: Biogen, Eisai Begin Submission of Subcutaneous Leqembi

Last month, the companies began a rolling submission for a subcutaneous autoinjector for weekly dosing of Leqembi. The companies originally had aimed to submit the weekly subcutaneous formulation to the FDA in March 2024. But the FDA required an additional three-month immunogenicity data at the proposed maintenance dose of 360 mg.

Data released October 2023 suggested weekly subcutaneous administration of Leqembi removed 14% more amyloid plaque in patients with Alzheimer’s disease than the biweekly intravenous formulation,

In January 2024, Biogen announced that stopped selling its Alzheimer’s drug Aduhelm (aducanumab-avwa) and will focus its resources on Leqembi and research of other treatments for Alzheimer’s disease.

Aduhelm had received accelerated approval from the FDA in June 2021, and Biogen was conducting post-marketing confirmatory ENVISION study. The company said in a press release it will stop the ENVISION study and direct resources toward other Alzheimer’s programs, including an antisense oligonucleotide licensed from Ionis that targets tau (BIIB080) and an oral small molecule inhibitor of tau aggregation (BIIB113).