Eli Lilly expects FDA decision on donanemab by year-end

Eli Lilly The company said on Monday it has applied to the U.S. Food and Drug Administration for full approval of its Alzheimer’s disease drug donanemab and expects the agency to make a decision By the end of this year.

Following Eisai and Biogen’s The drug Leqembi won FDA approval this month.The agency’s sign-off is a milestone Alzheimer’s Treatmentalthough drugs cannot cure it.

FDA approval of Eli Lilly’s donanemab expands more treatment options 6000000 Americans of all ages are living with Alzheimer’s.

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

According to the final results, donanizumab significantly slowed the progression of Alzheimer’s disease in patients in the early stages. These patients also demonstrated the presence of brain plaques associated with the disease.

The Alzheimer’s Association, an advocacy group for people with the disease, said it “strongly supports” the FDA’s approval of doramumab based on the positive results, which confirmed the company’s early May Preliminary data released.

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

In the phase 3 trial, patients who received donanemab experienced a 35% slower decline in memory, thinking and daily activities at 76 weeks (about a year and a half of treatment) compared with patients who received a placebo.

Patients in the earlier stages of the disease benefited more from donanemab, slowing the rate of cognitive decline by 60%.

Maria Carrillo, president of the Alzheimer’s Association, said: “The results suggest that starting treatment earlier may have a greater beneficial effect, and that even when treatment is started later in disease progression, it may slow Disease progression,” science officials said in a statement.

During the trial, patients taking donanemab were nearly 39 percent less likely to progress to the next stage of Alzheimer’s disease.

According to the final trial results, nearly half (47%) of patients treated with donanumab were free of disease progression one year after starting treatment. This compared with 29 percent of patients who did not receive the drug.

More than half of patients completed treatment within the first year, and 72 percent completed treatment within 18 months due to plaque clearance.

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

But doramumab also carries risks.

This treatment can cause swelling and bleeding in the patient’s brain, which can be serious or even fatal in some cases.

According to Lilly, three trial participants died from these side effects. More than 800 patients received donanemab in the trial.

These side effects have also been observed with other Alzheimer’s disease antibody treatments, such as Leqembi.