Eli Lilly announces plan to ask FDA for accelerated approval of new Alzheimer's drug
The company appears to have precedent with the FDA having approved an Alzheimer's drug from Biogen earlier this year.
American pharmaceutical company Eli Lilly announced Thursday that it will ask the Food and Drug Administration to approve its new Alzheimer's drug before the end of the year.
The company appears to have a precedent for such as request, the FDA approving a similar drug from Biogen earlier this year.
The Eli Lilly drug is called donanemab and has been a "breakthrough therapy" designation, given by the FDA to drugs the agency needs quickly or believes will improve already established therapies.
Lilly plans to petition its drug to the FDA after completing phase II trials, which have 272 patients. The company has already begun phase III, but it's unclear whether it will wait for those results before requesting approval.
Prior to Biogen's drug, it had been 20 years since new medication for Alzheimer's was available. According to the Centers for Disease Control and Prevention, about 5.8 million people were living with Alzheimer's in 2020.