US FDA staff raise no major concerns about Eli Lilly Alzheimer’s drug By Reuters

By Bhanvi Satija and Julie Steenhuysen

(Reuters) -An FDA analysis of trial data for Eli Lilly (NYSE:)’s experimental Alzheimer’s drug donanemab released on Thursday revealed no red flags, but raised questions about safety of the treatment for patients with early-stage disease.

The drug is a potential rival to Eisai and Biogen (NASDAQ:)’s Leqembi, which won approval last July.

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

An outside panel of FDA advisers will consider the staff’s view during a meeting on Monday in which they will vote on whether the drug’s benefits outweigh its risks, according to documents published on the agency’s website. The panel’s recommendations are non-binding but typically followed by the U.S. Food and Drug Administration.

If donanemab is approved, FDA staff said they expect its prescribing label to highlight several risks and strategies to mitigate those risks, which include brain swelling and bleeding, especially in people with two copies of a gene called ApoE4.

Post-approval requirements that may also be requested include expedited reporting of any deaths in ongoing studies of the drug and collection of data about side effects through a patient registry, FDA staff reviewers added.

At least two analysts said they expect donanemab will be approved.

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

RBC analyst Brian Abrahams said in a research note that overall, the agency’s comments may slightly favor Leqembi due to fewer adverse side effects, but with the FDA appearing inclined to approve the Lilly drug.