By Mariam Sunny and Maggie Fick
(Reuters) -The EU medicines regulator on Friday rejected Eli Lilly’s Alzheimer’s drug, saying the treatment’s ability to slow cognitive decline was not large enough to outweigh the risk of serious brain swelling in patients.
The regulator’s rejection of the drug, Kisunla, means Eisai and Biogen’s Leqembi treatment 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 plans to seek re-examination of the CHMP’s opinion.
There are about 7 million people with Alzheimer’s disease in Europe, according to the European Brain Council.
“It is difficult to understand the CHMP’s negative opinion on a drug which has been approved by regulators in the U.S., UK, China and Japan, based on the same scientific evidence,” non-profit group Alzheimer Europe said in a statement.
U.S. BOTTLENECKS
The adoption of this class of drugs has been slow in the United States, underscoring the complexities tied to its use, including additional diagnostic tests and regular brain scans to guard against potentially lethal side effects.
Like Leqembi, Kisunla is designed to clear sticky clumps of a protein called amyloid beta, believed to be a hallmark of Alzheimer’s, from the brain.
Lilly has expanded its direct-to-consumer online platform LillyDirect to include telehealth providers to diagnose and care for patients with Alzheimer’s disease, in its efforts to boost Kisunla sales.
Kisunla, which is given as a monthly infusion and has an annual U.S. list price of around $32,000, brought in sales of $9.3 million last year.
Shares of Lilly were marginally down in early trading.
“Limited reaction shows Alzheimer’s continues to diminish as a key contributor to Lilly’s enterprise value,” said Kevin Gade, chief operating officer at investment firm Bahl & Gaynor, which owns Lilly shares.
ADOPTION IN EUROPE
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 health risks.
The regulator 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.
Experts have also voiced concerns regarding the pricey Leqembi treatment’s wider adoption in cost-conscious countries within Europe. Leqembi costs $26,500 annually in the U.S.
Lilly had said last year that adopting a gradual dosing schedule for Kisunla helped reduce the risk of brain swelling, citing interim data from a late-stage trial.
(Reporting by Mariam Sunny, Padmanabhan Ananthan and Sriparna Roy in Bengaluru; Maggie Fick in London; Editing by Sriraj Kalluvila and Anil D’Silva)
