On 28 January 2025, the European Commission asked the Committee for Medicinal Products for Human Use (CHMP) to re-consider the positive opinion granted to Eisai/Biogen’s Leqembi® (lexanemab) in November 2024 for early Alzheimer’s disease following safety information that has since become available. The CHMP is expected to provide its response after its plenary meeting in February 2025. According to Biogen, “the safety profile of Leqembi® reported in clinical practice in the United States, Japan and other countries after launch is consistent with that in the approved labels, and no new safety signals are identified”.
In other news for the product, on 26 and 27 January 2025, Eisai and Biogen announced that the US FDA has approved Leqembi® for once every four weeks intravenous (IV) maintenance dosing, indicated for the treatment of Alzheimer’s disease (AD) in patients with mild cognitive impairment (MCI) or mild dementia stage of disease. Patients may transition to four-weekly dosing after 18 months of a fortnightly initiation phase.
Earlier this month, Eisai and Biogen also announced that the US FDA accepted Eisai’s BLA for Leqembi® subcutaneous autoinjector for weekly maintenance dosing for the same indications.
Leqembi® is approved for MCI and Early Alzheimer’s disease in the UK, US, Japan, China, South Korea, Mexico, Hong Kong and Israel, and the UAE. According to Eisai, applications are under review in Brazil, Canada, India, Russia, Taiwan, Singapore, Saudi Arabia and Switzerland. In October 2024, Australia’s Therapeutic Goods Administration (TGA) rejected Leqembi® due to safety and efficacy concerns.