On Friday, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a negative opinion on the approval of Eisai Co., Ltd ( ESALF ) (OTC:ESALF) and Biogen Inc.’s lecanemab.

The companies seek approval for the humanized anti-soluble aggregated amyloid-beta (Aβ) monoclonal antibody as a treatment for early AD (mild cognitive impairment due to Alzheimer’s disease (AD) and mild AD).

The committee considered that the observed effect of Leqembi on delaying cognitive decline does not counterbalance the risk of serious side events associated with the medicine, in particular, the frequent occurrence of amyloid-related imaging abnormalities involving swelling and potential bleedings in the brain of patients who received Leqembi.

Also Read: Biogen’s Leqembi Commercial Ramp-Up Modest But Up Ticking, Reports Mixed Bag Q1 Earnings.

In March, Biogen and Eisai ( ESALF ) faced a regulatory setback when Oral Explanation slated for March 19 at the CHMP was postponed. 

In June, the FDA’s advisory committee delivered a favorable verdict on the Eli Lilly And Co’s Alzheimer’s treatment donanemab, declaring its benefits to surpass the associated risks.

“We are extremely disappointed by the CHMP’s negative opinion and understand that this may also be disappointing for the wider Alzheimer’s disease community,” said Lynn Kramer, Chief Clinical Officer at Eisai ( ESALF ).

Eisai ( ESALF ) will seek re-examination of the CHMP opinion and work with the relevant authorities to ensure this treatment is available for eligible people living with early AD in the European Union (EU) as soon as possible.

Lecanemab has already been approved in the United States, Japan, China, South Korea, Hong Kong, and Israel, and it is being marketed in the U.S. (as Leqembi), Japan, and China.

AD currently affects 6.9 million people in Europe, which is expected to nearly double by 2050 as aging populations increase.

Eisai ( ESALF ) serves as the lead for lecanemab’s development and regulatory submissions globally. Both Eisai ( ESALF ) and Biogen co-commercialize and co-promote the product, and Eisai ( ESALF ) has final decision-making authority.

Price Action: BIIB stock is down 6.11% at $213.55 at the last check on Friday.

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