(Bloomberg) -- Eisai shares sink more than 12%, the most in three years, after European drug regulators rejected an Alzheimer’s therapy jointly developed with Biogen Inc., in what could be a blow to their global sales expansion plan.
The European Medicines Agency’s Committee for Medicinal Products for Human Use, or CHMP, recommended refusing granting of marketing authorization for Leqembi, citing safety concerns including side effects that involve swelling and potential bleeding in the brain.
Eisai, Biogen Alzheimer’s Drug Denied by European Regulators
This is “a very big negative surprise” given the EU approval was widely expected, Jefferies analysts including Stephen Barker wrote in a note. Even if the drug gets approved through appeal, it will likely be accompanied with a “highly restrictive label,” they said.
Tokyo-based Eisai said in a joint statement with Biogen that it was “disappointed” by CHMP’s decision. Among other firms researching Alzheimer’s treatment, Eli Lilly & Co. was granted approval in the US this month for the second drug to slow progression of the disease.
©2024 Bloomberg L.P.
