Biogen Inc. (NASDAQ: BIIB), a US biotechnology company, and its Japanese counterpart Eisai Co., Ltd have encountered a setback in their efforts to secure European approval for Leqembi (lecanemab), an Alzheimer’s disease therapy. The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a negative opinion on the drug’s marketing authorization application (MAA) for the treatment of early Alzheimer’s disease, which includes mild cognitive impairment and mild Alzheimer’s dementia.
The CHMP’s decision was based on a perceived insufficient cognitive benefit of lecanemab—citing a 1.21 point improvement over 18 months compared to a 1.66 point improvement with a placebo—as this was not deemed sufficient to offset the risks associated with the medication. The primary safety concern is amyloid-related imaging abnormalities (ARIA), which can manifest as brain swelling or bleeding (edema) and, in rare cases, lead to severe outcomes such as seizures or death. The CHMP noted that while most ARIA cases in the main study were mild and asymptomatic, some patients experienced serious events, including significant brain hemorrhages requiring hospitalization.
This decision is particularly contentious given that clinical trials have indicated lecanemab has a relatively low rate of ARIA-E (edema) at 12.6%, compared to other amyloid-targeting therapies such as the US-approved aducanumab (30%) and donanemab (24%). The safety profile of lecanemab was not heavily scrutinized during its approvals in the US, China, and Japan. It is also noteworthy that the CHMP previously refused to endorse Eisai and Biogen’s first amyloid-targeting drug, Aduhelm (aducanumab), despite its US approval.
Eisai, in its press release, stated its intention to re-evaluate the CHMP’s opinion and expressed its commitment to work with regulatory authorities to make the treatment available for early Alzheimer’s disease patients in the EU as soon as possible.- Flcube.com
