EU Regulator Rejects Eisai and Biogen’s Alzheimer’s Drug Leqembi
EU rejects Eisai and Biogen’s Alzheimer's drug Leqembi over serious brain swelling risk.
Breaking News
Jul 27, 2024
Mrudula Kulkarni

(Reuters) --The European Union's drugs regulator has
rejected Eisai and Biogen's Leqembi treatment for early Alzheimer's disease,
citing the risk of serious brain swelling as a significant disadvantage. The
decision is a blow to the companies as the drug faces slow take-up in the U.S.
and underscores the complexities of a new class of drugs that have benefited
early stage patients but could cause rare and serious side effects. Biogen's
shares fell about 7% in U.S. trading after the rejection, while rival Eli
Lilly, which makes a similar drug, slipped 1%. Eisai and Biogen said they will
seek reexamination of the recommendation, but did not disclose what information
they would provide the regulator.
Leqembi, also known as lecanemab, is approved in the U.S.,
China, Hong Kong, Israel, Japan, and South Korea. In clinical trials, the drug
slowed cognitive decline by 27% in early Alzheimer's patients, compared with a
placebo. In Europe, 7 million people live with the disease, according to
nonprofit Alzheimer's Europe. The EU regulator relied on the analysis by the
agency's Committee for Medicinal Products for Human Use and cited three primary
concerns: an 18-point scale used in the trial showed only a small absolute
difference in patients who received lecanemab versus a placebo, cases of ARIA,
a type of brain swelling and bleeding seen in its clinical trials that led to
hospitalizations of some patients, and elevated risk of brain swelling and
bleeding in people with two copies of the APOE4 gene, which is also associated
with a higher risk of Alzheimer's.