US FDA panel to vote on data, safety profile of Lilly Alzheimer’s drug

(Reuters) -A panel of outside experts to the U.S. health regulator will meet on Monday to vote on safety and efficacy data for Lilly’s <LLY.N> donanemab, a potential rival to Eisai and Biogen’s Leqembi, and make recommendations to the FDA.

Both the drugs are antibodies designed to remove toxic beta amyloid plaques from the brains of people with early Alzheimer’s disease.

The panel will also vote on whether benefits of the treatment outweigh its risks, documents published on the agency’s website on Thursday showed.

Its recommendations are non-binding but typically followed by the U.S. Food and Drug Administration.

Staff advisers to the health regulator recommended that if Lilly’s donanemab is approved, then certain risk factors such as brain bleeding should be identified in the prescribing information.

Reviewers said certain post-approval requirements may be requested, including expedited reporting of any deaths in ongoing studies of donanemab.

Drugs like donanemab and Leqembi, which are designed to slow disease progression in early-stage patients, represent a new era in the treatment of Alzheimer’s, after three decades of failed attempts to fight the fatal disease.

More than 6 million Americans have some form of the mind-wasting condition, according to the Alzheimer’s Association.

Alzheimer’s trials have previously found safety concerns such as brain swelling and bleeding associated with this class of drugs. In Lilly’s trial, three participants died from complications linked to the treatment.

(Reporting by Bhanvi Satija in Bengaluru, Deena Beasley in Los Angeles and Julie Steenhuysen in Chicago; Editing by Bill Berkrot and Arun Koyyur)