Nov 14 (Reuters) - The European Union's drugs regulator

on Thursday recommended approval for Eisai ( ESALF ) and Biogen's

Leqembi in some patients with early Alzheimer's

disease, nearly four months after it first rejected the

treatment.

The backing could make it the first treatment in the EU

for the mind-wasting condition if the recommendation is accepted

by the European Commission and adopted widely by European Union

member states.

The agency's human medicines committee (CHMP) said it

recommends approval for the drug in patients who have only one

or no copy of ApoE4 gene variant, which is linked with an

earlier onset of the disease.

Once a marketing authorisation has been granted,

decisions about pricing and reimbursement will take place at the

level of each member state, taking into account the potential

role and use of Leqembi in the context of its national health

system.

In this restricted population, which was assessed in its

re-examination of the drug, benefits of Leqembi in slowing down

progression of symptoms of the disease are greater than its

risks, the agency said. In the United States, the drug is

approved for patients who have two copies of the gene ApoE4.

"This decision provides hope for the millions of EU

patients and their families who have been waiting for an

effective treatment option," said Priya Singhal, head of

development at Biogen. Shares of the U.S. drugmaker rose about

2%.

In July, the agency had rejected approval for the drug,

saying the risk of serious brain swelling did not outweigh its

small impact on slowing cognitive decline.

The EU regulator says patients with only one or no copy

of ApoE4 are less likely to experience serious side effects of

brain swelling and potential bleeding seen in Leqembi trials.

For the re-examination, Eisai ( ESALF ) and Biogen provided an

analysis of a group of 1,521 patients from the main study who

have one or no ApoE4 copy out of total of 1,795 patients.