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EU regulator delays decision on Eisai-Biogen Alzheimer's drug
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EU regulator delays decision on Eisai-Biogen Alzheimer's drug
Mar 22, 2024 5:23 AM

March 22 (Reuters) - The European Union's medicines

regulator has delayed it decision on Eisai ( ESALF ) and partner

Biogen's 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 a oral hearing to discuss the drug, lecanemab, this week.

Eisai ( ESALF ) 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,"

Eisai ( ESALF ) said.

The EMA will schedule a new meeting of its experts in the

future to decide on the drug, Eisai ( ESALF ) said.

"The evaluation of lecanemab is still ongoing," the EMA

said, adding that it would communicate the decision when it had

one.

The drug, sold as Leqembi in the United States has been

under review in Europe since January 2023. It gained traditional

approval in the United States last year and is also approved in

other countries, including China and Japan.

In Europe, 7 million people are living with the

brain-wasting disease, and that figure is expected to double by

2050, according to Alzheimer's Europe.

The 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.

(Reporting by Manas Mishra and Puyaan Singh in Bengaluru;

Editing by Alan Barona, Josephine Mason and Shinjini Ganguli)

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