Alzheimer’s drug donanemab shows positive results, Eli Lilly asks for approval

Eli Lilly Monday said application The U.S. Food and Drug Administration fully approves its Alzheimer’s disease drug donanemab, and expects the agency to make a decision By the end of this year.

The application is based on positive Phase III Clinical Trial Results Donanemab significantly slowed disease progression in patients with early-stage Alzheimer’s disease.

The results also showed that treating patients in the earliest stages of the disease could slow the progression of Alzheimer’s disease by about 40% to 60%.

Eli Lilly CEO: ‘The earlier the drug is started, the slower it may be’ david ricks In an interview with CNBC’s “Squawk on the Street” on Monday.

Eli Lilly (Eisai) and Biogen’s The drug Leqembi won FDA approval this month.The agency’s endorsement of Leqembi is a milestone in the field Alzheimer’s Treatmentalthough drugs and donanizumab are not a cure.

Both treatments are monoclonal antibodies that target amyloid plaques in the brain, which are considered a hallmark of the disease.

FDA approval of Eli Lilly’s donanemab expands more treatment options 6000000 Americans of all ages living with Alzheimer’s fifth leading cause of death Suitable for adults over 65 years old.

The company did not say how it would price donanizumab after possible approval.

But the Centers for Medicare and Medicaid Services says Medicare will cover Alzheimer’s drugs — as long as they are fully approved by the FDA and the healthcare provider participates in the registry system, which collects data on how the drug works in the real world.

Ricks said the registration requirement appeared to be a “pretty painless thing” that didn’t “require much effort”. But he noted that the data that would be collected in the process appeared to be of “pretty low value”.

“So, we hope that in time for doramumab to be approved, that (requirement) will be lifted and it will be fully covered,” Ricks told CNBC.

Eli Lilly also announced Monday the final results of an 18-month Phase 3 trial of donanemab, a monthly antibody infusion, at the National Institutes of Health. Alzheimer’s Association International Conference in Amsterdam, Netherlands. The results confirmed preliminary data released by the company in early May.

The final results also address FDA’s previous concerns that reject Eli Lilly filed for accelerated approval in January for donanemab. At the time, the agency asked the company to provide more data on patients who had been treated for at least 12 months.

The trial followed more than 1,700 early-stage Alzheimer’s patients with confirmed amyloid plaques. About half of the participants received donanizumab.

Compared with patients who received a placebo, those who received donanemab experienced a 35% slower decline in memory, thinking skills and daily activities at week 76 (approximately one and a half years of treatment).

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

The trial also found that 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.

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.

“The results suggest that starting treatment earlier may have a greater beneficial effect and may slow disease progression even when treatment is started at a later age,” said lead scientist Maria Carrillo. Haimer’s Disease Association officials said in a statement.

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

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.”

After six months, donanemab cleared amyloid plaques in 34 percent of patients with moderate levels of the tau protein, which is toxic and kills neurons.

At 76 weeks, donanemab cleared plaque in about 80 percent of patients with the same tau levels. In comparison, people who took a placebo over the same time period had a 0 percent plaque clearance rate.

However, the benefits and risks of donamumab must be weighed.

Drugs that target and remove amyloid plaques can cause brain swelling and bleeding in patients, which can be serious and even fatal in some cases.

Nearly 37 percent of people taking donanemab experienced these side effects, called amyloid-related imaging abnormalities, compared with nearly 15 percent of people taking a placebo, the trial results showed. According to Lilly, three trial participants died from these side effects.

These side effects were also observed this group.