March 28 (Reuters) - The European Union's drugs
regulator on Friday rejected Eli Lilly's ( LLY ) 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 ( ESALF )
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)