(Reuters) -The European Union’s drugs regulator on Friday rejected Eli Lilly’s Alzheimer’s drug, saying the risk of serious brain swelling did not outweigh the treatment’s small impact on slowing cognitive decline.
The rejection of the drug, Kisunla, means Eisai and Biogen’s Leqembi will likely pull ahead in the race to become the EU’s first approved Alzheimer’s treatment, if the European Commission accepts the agency’s recommendation on the rival drug.
The EU regulator’s Committee for Medicinal Products for Human Use (CHMP) in February reiterated its positive recommendation for Leqembi after concluding a safety review.
Lilly said it would seek re-examination of the CHMP’s opinion.
“We hope that through the re-examination process, we will be able to continue our discussions with the agency to bring donanemab (Kisunla) to the millions of people across Europe suffering from this relentless, fatal disease,” said Ilya Yuffa, executive vice president at Lilly.
(Reporting by Mariam Sunny and Padmanabhan Ananthan in Bengaluru; Maggie Fick in London; Editing by Shreya Biswas and Sriraj Kalluvila)
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