Eli Lilly and Company announced on Thursday that the U.S. Food and Medicine Administration had denied fast approval of its experimental Alzheimer’s drug due to insufficient trial results from patients who had been treated for at least one year.
As per a report by Reuters, Donanemab, an antibody designed to eliminate amyloid protein plaques from the brains of persons with early Alzheimer’s, has received a complete response letter from the FDA, according to Lilly. Typically, these letters explain concerns and requirements that must be met to obtain U.S. approval.
Eli Lilly stated that the FDA issued the letter “because of the limited number of patients with at least 12 months of medication exposure data included in the submission.” In the mid-stage experiment, patients discontinued treatment after their amyloid was eliminated, which Lilly reported occurred in 40% of patients after six months.
“I don’t believe it contains any negative information concerning the medicine. It was merely an expression of the study’s design “Dr. Ronald Petersen, an Alzheimer’s specialist at the Mayo Clinic in Rochester, Minnesota, stated the following.
The company stated that it remained on pace to disclose data from a Phase 3 confirmatory trial of donanemab in the second quarter of this year. Lilly stated that this trial would serve as the foundation for donanemab’s application for conventional FDA clearance shortly thereafter.
Dr. Eric Reiman, executive director of Banner Alzheimer’s Institute, stated, “I do not see this as a hindrance to the process or schedule in any way.” According to my understanding, when the Phase 3 trial concludes, it will include safety data from at least 100 participants.
Russ Paulsen, chief operating officer of UsAgainstAlzheimer, stated that the advocacy group was “disappointed this medicine would not be made available to patients sooner” but was pleased by the explanation.
“Donanemab was too effective… Due to donanemab’s fast response in some patients, many were able to discontinue treatment in as little as six months, whereas the FDA requires at least 100 patients to be on the drug for at least 12 months “He stated through email.
The FDA can award “accelerated” approval to medications whose effect on a measurement, in this case, amyloid brain plaques, correlates with patient response. Complete approval of medicine requires clinical evidence that it improves patient outcomes. In after-hours trade, Lilly shares were down 1.4% to $346.02 per share.
Donanemab is in the same family as aducanumab and lecanemab, the latter of which received accelerated FDA approval this month as an early Alzheimer’s disease treatment. It is being marketed under the brand name Leqembi by partners Eisai Co Ltd (4523.T) and Biogen Inc (BIII.O), who have stated that they are pursuing FDA approval. Biogen stock rose 2.8% to $288 after hours.
It is anticipated that sales of amyloid-lowering Alzheimer’s medications that must be administered by infusion will be small until they get routine FDA approval. Medicare only reimburses amyloid-targeting medications with accelerated approval for patients enrolled in a validated clinical trial.
