Following the news that the FDA granted traditional full approval for Eisai and Biogen’s anti-amyloid beta (Aβ) monoclonal antibody (mAb) Leqembi (lecanemab) as the treatment of mild Alzheimer’s disease (AD) and mild cognitive impairment (MCI);

Philippa Salter, Senior Neurology Analyst at GlobalData, offers her view:

“The full approval for Leqembi is a pivotal moment for the AD market as the drug will become the first widely available disease-modifying therapy (DMT) for AD. Despite the drug receiving accelerated approval from the FDA in January 2023, the uptake of Leqembi has been severely limited by restricted Medicare coverage. However, upon receiving full approval, the US Centers for Medicare and Medicaid Services (CMS) decision to limit coverage to patients in clinical trials has been revoked, allowing for much broader coverage and significantly greater access to the drug.

“Based on its position as a first-to-market widely available DMT, Leqembi is expected to become the top-selling AD drug by 2030. GlobalData forecasts Leqembi to generate global (8MM*) sales of approximately $3.5 billion in 2030. In contrast, the CMS restriction still applies to Biogen’s Aduhelm (aducanumab), which was approved by the FDA in 2021, and as such has continued to stymie uptake of the drug.

“The decision from the CMS to now cover Leqembi fully is good news for Eli Lilly’s donanemab. This anti-Aβ mAb is expected to be the biggest competitor for Leqembi and the company will be targeting full approval for donanemab following the read-out of positive Phase III results in May this year; the drug demonstrated a comparable reduction in clinical decline to Leqembi considering the different endpoints used in the clinical trials for each drug. Whilst Leqembi does have the advantage of reaching the market before donanemab, an important competitive advantage for donanemab is its once monthly dosing schedule compared with once every two weeks for Leqembi. GlobalData forecasts donanemab to generate global (8MM*) sales of approximately $2.0 billion in 2030.”

*8MM: The US, France, Germany, Italy, Spain, the UK, Japan, and China.