EU regulator delays decision on Eisai-Biogen Alzheimer's drug

The Alzheimer's drug LEQEMBI is seen in this undated handout image obtained by Reuters on January 20, 2023. © Eisai/Handout via REUTERS/File

The European Union's medicines regulator has delayed its decision on Eisai (4523.T) and partner Biogen's (BIIB.O), opens new tab Alzheimer's disease drug that was expected this week, the Japanese company said on Friday.

On Monday, the European Medicines Agency had said it would hold an oral hearing this week to discuss the drug, lecanemab, which has been under review in Europe since January 2023.

Eisai said the delay was due to a EU court ruling last week, unrelated to the Alzheimer's drug, that had "implications on EMA's policy on the handling of competing interests of experts."

The EMA will schedule a new meeting of its experts in the future to decide on the drug, Eisai said. The drug gained traditional approval in the United States last year, where it is sold as Leqembi, and is also approved in China and Japan.

"The evaluation of lecanemab is still ongoing," the EMA said on Friday.

Any recommendation by the EMA's Committee for Medicinal Products for Human Use (CHMP) has to be formally approved by the European Commission, which usually follows the regulator's decision.

In Europe, 7 million people are living with the brain-wasting disease, and that figure is expected to double by 2050, according to non-profit Alzheimer's Europe.

RBC Capital Markets analyst Alistair Campbell said in a note the brokerage now expects an approval in the second half of 2024, versus Eisai's expectation of a decision in the quarter ending June 30.

Shares of partner Biogen were down 2% in morning trade.

Lecanemab, an infusion, given twice a month removes sticky clumps of a protein called amyloid beta, believed to be a hallmark of Alzheimer's, from the brain.

The drug was originally developed by Sweden-based BioArctic (BIOAb.ST). The company has the right to commercialize the drug in the Nordic region.

Source: Reuters