On January 31 (Reuters) - the European Medicines Agency announced that it will be reassessing safety data for Eisai and Biogen's Leqembi, nearly three months after originally recommending the drug's approval for treating some early-stage Alzheimer's patients.
The safety information became available post the initial recommendation, potentially prompting a reevaluation of the agency's previous stance on the drug.
Before being accessible to patients, any suggestions made by the EU regulator require approval from the European Commission.
This review, commissioned by the European Commission, adds to the delays in introducing what could possibly be the first treatment for Alzheimer's in the region. Leqembi has been under assessment in the region since [add missing information].
The medications authority anticipates responding to the commission in February but hasn’t disclosed specifics on the safety data under review.
While Eisai did not divulge the specifics of the safety data, they mentioned that the information currently under scrutiny had been previously analyzed by the U.S. FDA and the UK’s medication regulator.
Eisai has affirmed that no new safety alerts have surfaced regarding Leqembi, and its safety profile has remained unchanged throughout and after the EU's evaluation.
Eisai and Biogen affirmed in a joint statement that the safety profile of Leqembi post its launch in the U.S., Japan, and other nations aligns with earlier studies.
We are confident that the European Commission's concerns can be addressed with the current information available, the companies stated, and assured their commitment to working closely with the regulator.
Previously, the EU committee on human medicines had proposed approval for a more targeted patient group than those in the trial of Leqembi.
This approval recommendation marked a shift from previous refusals due to the risk of severe brain swelling.