Eli Lilly to apply for accelerated approval of unproven Alzheimer’s drug

The pharma giant is looking to take full advantage of the potential new precedent set by the Food and Drug Administration (FDA) following its approval of Biogen’s Aduhelm.

Eli Lilly on Thursday said it plans to submit its Alzheimer’s drug to FDA for accelerated approval later this year, a move that takes advantage of the agency’s controversial approval of a similar drug from Biogen.

The company in a statement said it intends to submit its drug called donanemab to the FDA by the end of the year, but it could happen much sooner.

Lilly said the agency gave donanemab a “breakthrough therapy” designation, which is meant to expedite the development and review of drugs that may demonstrate substantial improvement over already established therapies.

Context: The announcement from Lilly comes after the FDA overruled its own outside advisory panel earlier this year to approve Biogen’s drug Aduhelm, saying it was “reasonably likely” the treatment would slow cognitive decline in patients. Aduhelm was granted accelerated approval based on a “surrogate endpoint.”

Instead of basing the decision on whether the drug slows cognitive decline, FDA granted approval based on the reduction of amyloid plaque in the brain. FDA officials have since defended the decision and said there is evidence that shows plaque reduction helps patients, but many experts are not so sure.

Lilly’s drug: Donanemab is also an amyloid-reducer, and the company said it will file for approval based on the results of a mid-stage clinical trial involving 272 patients. The company is conducting a larger phase 3 trial, but Thursday’s announcement indicates the company is not going to wait for the results.