After delay, Alzheimer's drug Leqembi gets green light in EU

 The European Commission has approved Eisai and Biogen's Leqembi for a subset of patients with early-stage Alzheimer's disease, setting it up to become the first amyloid-targeting drug to reach the EU market.

As expected, there are restrictions on the use of Leqembi (lecanemab), which has been cleared for patients with a clinical diagnosis of mild cognitive impairment and mild dementia due to Alzheimer's disease who have only one or no copy of the ApoE4 genetic variant.

The EMA's human medicines committee, the CHMP, recommended against the approval of Leqembi in July 2024 on the grounds that its modest efficacy was outweighed by potentially serious side effects. That decision came despite prior approvals for Leqembi in the US, China, and Japan, and ahead of a go-ahead in the UK.

Patients with only one or no copy of ApoE4 are less likely to experience so-called ARIA side effects, like brain swelling and bleeding, associated with amyloid-targeting drugs, than people with two ApoE4 copies.

The CHMP subsequently changed its view and backed approval with the restricted label, although, the process was held up by a fresh safety review that kicked off in January and has been formally brought to a close with the Commission's decision to approve Leqembi – more than two years after Eisai and Biogen first filed their application.

In a statement, the Commission said that the assessment "concluded that the benefits of this medicine outweighed the risks in a particular population of patients with such disease and as long as risk minimisation measures are applied."

Eisai and Biogen said that Leqembi has become the first therapy that addresses an underlying disease mechanism in Alzheimer's, in contrast to previously approved drugs that boost neurotransmitters in the brain and temporarily prop up its functioning.

A rival amyloid therapy from Eli Lilly – Kisunla (donanemab) – was rejected by the CHMP in March, even though the company proposed restricting its label to include only people with no ApoE4 gene copies. That decision has now gone to appeal.

According to Eisai's chief executive, Haruo Naito, the company is "working collaboratively with national reimbursement authorities and healthcare providers to support access for those eligible for lecanemab as soon as possible."

The Japanese drugmaker is taking the lead on Leqembi's development and regulatory submissions globally, with both companies co-promoting Leqembi across Europe other than Nordic countries, where it will be co-promoted by Eisai and BioArctic.

The EU approval comes after Eisai and Biogen were given approval for a new once-monthly intravenous maintenance dose of Leqembi in the US, after a biweekly IV initial induction course, that would reduce the number of visits needed to an infusion clinic.

The two companies are also hoping to get the go-ahead later this year for a new subcutaneous autoinjector formulation that could be administered at home.

Sales growth for the drug has proven to be sluggish, although, Eisai has predicted it will cross the $1 billion threshold in fiscal 2027, which ends in March 2028.

https://pharmaphorum.com/news/after-delay-alzheimers-drug-leqembi-gets-green-light-eu