Eisai and Biogen can finally put their European regulatory uncertainty surrounding Alzheimer's disease medicine Leqembi behind them and focus on the drug's launch in the region.
After months of back-and-forth decisions by European officials, the European Commission (EC) on Tuesday made the final call to bless the Alzheimer’s drug with a marketing authorization, albeit in a restricted patient population.
Leqembi is now cleared to treat mild cognitive impairment in those with early stages of Alzheimer’s in Europe under “strict conditions,” the commission announced. The drug can only be used in people who have one or no copies of the ApoE4 gene and who have amyloid beta plaques in their brain. That’s the patient population for whom the European Medicines Agency (EMA) previously determined Leqembi’s benefits would outweigh its risks, “as long as risk minimization measures” are also applied, the commission noted.
It’s a decision that marks the end to a twisting regulatory path for the drug in Europe. Last summer, the EMA's Committee for Medicinal Products for Human Use (CHMP) recommended against use of the drug, prompting Eisai to express at the time that it was "extremely disappointed."
Several months later, a reexamination yielded a positive outcome for the drug, albeit in a restricted population and with rules that patients must get MRI scans at specific intervals during the course of treatment.
Regulators limited the eligible patient pool because those with two copies of ApoE4 are at a higher risk of brain swelling or bleeding side effects known as amyloid-related imaging abnormalities (ARIA).
After the November 2024 endorsement, the EC asked the CHMP to weigh new safety data that came out after its November opinion. The committee ultimately signed off on the drug again after evaluating the new data, reconfirming its positive opinion in February.
Then, the decision moved back to the EC as the region’s ultimate drug authorization authority.
Not only has Leqembi now finally crossed the European finish line, but it’s the first of its kind to do so after Eli Lilly’s rival Alzheimer’s med Kisunla was rejected in March over similar ARIA-related safety concerns. Lilly intends to seek a reexamination of the agency’s March decision, the company said at the time.
The newly unlocked European patient population is an important part of Leqembi’s growth story, especially considering the med's sluggish U.S. launch since its initial FDA approval in 2023. The drug pulled in around 13.3 billion Japanese yen ($87 million) worldwide in the third quarter of Eisai’s 2024 fiscal year, which just ended March 31.
Besides the U.S., officials in Japan, China, Great Britain, Mexico and several other countries have endorsed the medicine.
Now, Leqembi is on the cusp of a “growth expansion phase,” Eisai’s chief operating and growth officer Keisuke Naito said during a February earnings call. Improvements in awareness, diagnostic guidelines and a new dosing schedule recently approved in the U.S. should all help stir up future growth, Eisai execs have said.