Eli Lilly expects an FDA decision on the Alzheimer’s treatment with donanemab by the end of the year

Eli Lilly said Monday that it has applied for full approval from the U.S. Food and Drug Administration for the treatment of Alzheimer’s disease, donanemaband expects the agency to be decide until the end of the year.

Eli Lilly is among the pharmaceutical companies vying to market new drugs for this mind-robbing disease Eisai and Biogenov medicine Leqembi got FDA approval this month. The agency’s signature was a milestone in treatment of Alzheimer’s diseasealthough medicine is not a cure.

FDA approval of Eli Lilly’s donanemab would expand treatment options by more than 6 million Americans of all ages who have Alzheimer’s disease.

Eli Lilly also presented the final results of an 18-month phase III trial of the monthly infusion of the antibody donanemab at the Alzheimer’s Association International Conference on Monday.

According to the final results, donanemab significantly slowed the progression of Alzheimer’s disease in patients in the early stages of the mind-robbing disease. These patients also had the confirmed presence of brain plaques associated with the disease.

The Alzheimer’s Association, an advocacy organization for people with the disease, said it “strongly supports” the FDA’s approval of donanemab, based on positive results that confirm initial data the company released in early May.

The final results address earlier concerns from the FDA, which in January rejected Eli Lilly’s request for accelerated approval of donanemab. At the time, the agency asked the company for more data on patients who had been treated for at least 12 months.

In a phase III trial, patients receiving donanemab showed a 35 percent slower decline in memory, thinking and their ability to perform daily activities after 76 weeks — about a year and a half of treatment — compared to those receiving a placebo.

Patients in the earliest stages of the disease benefited more from donanemab, showing a 60% slower decline in cognitive function.

“The results show that starting treatment as early as possible offers the possibility of a greater beneficial effect, but also that there is a possibility of slowing the progression of the disease, even if treatment is started later in the progression of the disease,” said Maria Carrillo, head of the Alzheimer’s Association. science officer, in a statement.

Patients taking donanemab were nearly 39% less likely to progress to the next stage of Alzheimer’s disease during the trial.

Nearly half of the patients — 47% — who received donanemab showed no disease progression one year after starting treatment, according to the trial’s final results. This compares to 29% for those who did not receive the drug.

More than half of the patients completed treatment within the first year, and 72% completed it within 18 months due to the removal of brain plaques.

The Alzheimer’s Association said this data point is “important to patients, families, prescribers and payers because patients may not need to receive this treatment for the rest of their lives.”

But donanemab also carries risks.

The treatment can cause brain swelling and bleeding in patients, which in some cases can be severe and even fatal.

Three trial participants died from these side effects, Lilly says. More than 800 patients received donanemab in the trial.

These side effects have been seen with other anti-Alzheimer antibody treatments, such as Leqembi.