A European regulatory committee has changed its stance on the Alzheimer’s medication lecanemab, recommending it for approval several months after initially rejecting the treatment.
On Thursday, Biogen announced that the drug, known in the United States as Leqembi, has received a favorable evaluation from the European Medicines Agency’s Committee for Medicinal Products for Human Use, targeting early-stage Alzheimer’s disease.
The next step involves the European Commission, which is expected to reach a marketing authorization decision within a few months.
Back in July, the committee expressed reservations, stating that the risks associated with the drug’s side effects outweighed its benefits in delaying the progression of this debilitating disease. However, Japanese pharmaceutical company Eisai urged the committee to review its previous decision.
Eisai is the developer of Leqembi and collaborates with Biogen, based in Cambridge, Massachusetts, to co-market the medication.
Leqembi functions by clearing amyloid plaques from the brain, one of the hallmarks associated with Alzheimer’s disease. Clinical trials have demonstrated that it can slow the decline in memory and cognitive functions by several months in comparison to participants who were administered a placebo.
However, the treatment carries risks, including potential brain swelling and bleeding, which can be severe in rare instances.
The drug secured full approval from the U.S. Food and Drug Administration last year, and it has gained approval from various regulatory bodies in other nations as well.
Additionally, the FDA approved another competing medication from Eli Lilly and Co. in July, indicating a growing interest in treatments for Alzheimer’s disease.