EMA/CHMP November recommendations include Leqembi U-turn

The European Medicines Agency’s (EMA) human medicines committee (CHMP) made a number of recommendations at its November meeting, notable among which was a reversal of a previous rejection of Alzheimer’s drug Leqembi (lecanemab).

Following a re-examination, the CHMP has recommended granting a marketing authorization for Leqembi(lecanemab), from Japanese drugmaker Eisai (TYO: 4523),for the treatment of mild cognitive impairment (memory and thinking problems) or mild dementia due to Alzheimer’s disease (early Alzheimer’s disease) in patients who have only one or no copy of ApoE4, a certain form of the gene for the protein apolipoprotein E. During the re-examination, Eisai provided additional analyses of the data to support the proposed use in a subgroup of patients. The committee concluded that in the restricted population of patients who have only one or no copy of ApoE4, the benefits of Leqembi outweigh the risks.

The committee recommended granting a conditional marketing authorization for Bristol Myers Squibb’s (NYSE: BMY) Augtyro (repotrectinib), a medicine intended for the treatment of adults and adolescents with advanced solid tumors, and adults with locally-advanced or metastatic non-small cell lung cancer.