The European Commission gave its approval on Tuesday for the use of a drug developed by Eisai and Biogen to treat certain individuals experiencing mild cognitive impairment in the early phases of Alzheimer’s disease, wrapping up a review process that spanned over two years.
This decision marks Leqembi as the first medication authorized in the European Union that directly targets a fundamental cause of this devastating brain disease. It had been under regulatory scrutiny since January 2023.
Priya Singhal, the head of development at Biogen, stated that the company and their partner Eisai are “moving with urgency” to ensure this therapy becomes available to patients across Europe.
A competing Alzheimer’s drug from Eli Lilly faced rejection last month, as its benefits were deemed insufficient to outweigh significant safety concerns.
The authorization specifies that Leqembi can be used to treat individuals who have either one or no copies of the ApoE4 gene and who exhibit the presence of sticky clumps of a protein known as amyloid beta in their brains, a substance widely believed to be a key characteristic of Alzheimer’s.
The decision to exclude those with two copies of the gene reflects the regulator’s cautious approach to safety, according to William Blair analyst Myles Minter. He projects peak sales for the drug to exceed $900 million in the 2030s.
The EC’s decision aligns with the stance of the European Medicines Agency, which recently reaffirmed that Leqembi would be approved for a more limited group of patients compared to those involved in its clinical trials.
While the regulator had initially supported Leqembi for patients with only one copy of the ApoE4 gene, the EC requested an additional safety evaluation. Earlier on, the European medicines regulator had actually declined to support the drug’s approval due to serious safety risks identified.
Leqembi has been approved in the United States for patients with two copies of the gene, but these individuals are required to undergo regular brain scans to monitor for any signs of brain swelling.
Furthermore, Leqembi has also received approval in Japan, China, Great Britain, and several other markets around the world.
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