EU Regulator Rejects Eli Lilly’s Alzheimer’s Drug

(Reuters) -The European Union’s drugs regulator on Friday rejected Eli Lilly’s Alzheimer’s drug, saying the treatment’s small impact on slowing cognitive decline was not large enough to outweigh the risk of serious brain swelling in patients.

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.

Kisunla and Leqembi achieved the long-awaited breakthrough after decades of failed attempts to find drugs to combat the fatal mind-wasting disease.

However, health regulators, wary of the risk of serious brain swelling and bleeding, have been particularly rigorous during the review process.

The CHMP recommended approval for Leqembi last year, after previously rejecting the treatment, saying the drug’s ability to slow cognitive decline did not outweigh the health risks.

The EMA recommended Leqembi’s use in a narrower set of patients – with one or no copy of a gene variant called ApoE4 – who are less likely to experience the serious side effects.

The EU medical regulator is far too slow compared with regulators in other countries, including the United States and Japan, in reviewing and authorizing breakthrough new treatments, Lilly’s Yuffa said in a statement shared with Reuters after the decision.

He criticized the medical regulatory environment in Europe, saying it was discouraging drugmakers from doing research and development on the continent.

The European Commission proposed its first overhaul of the bloc’s pharma regulation rules in 20 years two years ago, but that bill has not been passed into law by parliament.

The Commission said at the time that the new rules were meant to make it easier for innovative drugs to reach patients more quickly and in all European nations, but the pharma industry has said the rules would have the opposite effect of discouraging innovation.

There are about 7 million people with Alzheimer’s disease in Europe, according to the European Brain Council.

(Reporting by Mariam Sunny and Padmanabhan Ananthan in Bengaluru; Maggie Fick in London; Editing by Sriraj Kalluvila and Anil D’Silva)