Author: Bhanvi Satija and Julie Steenhuysen
(Reuters) – An FDA analysis of trial data released on Thursday for Eli Lilly & Co’s (NYSE: ) experimental Alzheimer’s drug donanezumab found no red flags but raised concerns about Questions have been raised about the safety of the treatment in patients with early-stage disease.
The drug is a potential rival to Eisai and Biogen’s (NASDAQ: ) Leqembi, which was approved last July.
Both treatments are antibodies designed to remove toxic beta-amyloid plaques from the brains of early-stage Alzheimer’s patients.
An FDA panel of outside advisers will consider the staff’s views at a meeting on Monday, where they will vote on whether the drug’s benefits outweigh its risks, according to documents posted on the agency’s website. The panel’s recommendations are nonbinding but are generally followed by the U.S. Food and Drug Administration.
FDA staff said that if donanemab is approved, they expect its prescription labeling to highlight multiple risks and strategies to mitigate those risks, including brain swelling and bleeding, particularly for people with two copies of the ApoE4 gene.
FDA staff reviewers added that post-approval requirements that may also be required include rapid reporting of any deaths in ongoing drug studies and collection of data on side effects through patient registries.
At least two analysts said they expected donanumab to be approved.
After three decades of failed attempts to find a treatment for this deadly, mind-sapping disease, drugs like Donanelimab and Leqembi, which aim to slow the progression of the disease, represent the first steps in Alzheimer’s disease. A new era of disease treatment.
Overall, the agency’s review may be slightly favorable to Leqembi due to fewer adverse side effects, but the FDA appears to be leaning toward approval, RBC analyst Brian Abrahams said in a research note. This drug from Eli Lilly and Company.
