Biogen and Eisai’s Alzheimer’s disease (AD) drug Leqembi (lecanemab) has been approved by the European Commission (EC).
The decision makes Leqembi the first therapy authorised in the EU that targets an underlying cause of the neurodegenerative disorder, the companies outlined.
The regulator has approved the drug to treat adults with a clinical diagnosis of mild cognitive impairment (MCI) and mild dementia due to AD (early AD) who have one or no copies of the ApoE4 gene with confirmed amyloid pathology.
AD is an irreversible and progressive disease that slowly destroys memory and thinking skills and, eventually, the ability to carry out simple tasks. AD currently affects an estimated 6.9 million people in Europe, while MCI due to AD impacts 15.2 million
Administered intravenously in a healthcare setting every two weeks, Leqembi works by binding to and reducing clumps of amyloid beta protein that form plaques in the brain.
The EC’s decision on the therapy was supported by positive results from the late-stage Clarity AD trial, in which treatment with Leqembi in the EU indicated population reduced clinical decline on the global cognitive and functional scale, CDR-SB, by 31% at 18 months compared to placebo.
Leqembi was also associated with a 33% reduction in decline compared to placebo at 18 months on the AD Cooperative Study-Activities of Daily Living Scale for Mild Cognitive Impairment, which measures information provided by people caring for AD patients.
Christopher Viehbacher, president and chief executive officer at Biogen, said: “The approval of [Leqembi] by the EC marks the thirteenth approval of this important medicine, which has already benefitted thousands of patients in the US, Japan and other regions of the world… This is a landmark advancement in a field where there has been no or little innovation in the past 20 years.”
Haruo Naito, Eisai’s chief executive officer, added that the company is “working collaboratively with national reimbursement authorities and healthcare providers to support access for those eligible for [Leqembi] as soon as possible”.
Eisai serves as the lead for Leqembi’s development and regulatory submissions globally, with both partners co-commercialising and co-promoting the product and Eisai having final decision-making authority.