FDA approves Eli Lilly’s Alzheimer’s drug donanemab | Wilnesh News

The U.S. Food and Drug Administration approved Tuesday Eli Lilly and CompanyAlzheimer’s drug donanemab expands limited U.S. treatment options for this mentally draining disease

The agency approved the therapy, which will be marketed under the brand name Kisunla, to treat adults with early symptoms of Alzheimer’s disease, according to the company.

almost 7 million Americans have this condition, fifth leading cause of death For adults 65 and older, according to the Alzheimer’s Association. By 2050, this group of people in the United States is expected to grow to nearly 13 million

It’s a long-awaited victory for Eli Lilly after donanezumab hit a roadblock on its road to market. The FDA rejected the drug’s approval last year due to insufficient data, then surprisingly delayed approval again in March. Earlier this month, an agency advisory panel recommended full approval of the treatment, saying its benefits outweighed its risks.

Donanemab will compete head-on with another treatment from Biogen and its Japanese partner Eisai, Leqembi, which has gradually been rolled out in the U.S. since it was approved last summer.

Donanemab and Leqembi are milestones in Alzheimer’s treatment, after three decades of failed efforts to develop drugs to combat the deadly disease. Both drugs are monoclonal antibodies that target toxic plaques in the brain called amyloid, a hallmark of Alzheimer’s, to slow the progression of the disease in patients in the early stages.

Eli Lilly’s drug slowed the progression of Alzheimer’s disease by 35% over 18 months compared with a placebo, according to a late-stage trial. After patients achieve certain goals of amyloid plaque clearance, they can end treatment and switch to placebo after 6, 12 or 18 months.

The drug is administered as a monthly infusion and costs an estimated $12,522 for a six-month course, $32,000 for a 12-month course, and $48,696 for an 18-month course. Eli Lilly said health insurance and reimbursement are available to eligible patients.

Neither treatment is a cure. Drugs that target and remove amyloid plaques may also have significant safety risks, including brain swelling and bleeding that can be serious or even fatal in some cases.

Three patients who took Eli Lilly’s drug in a late-stage trial died from severe side effects called amyloid-related imaging abnormalities (ARIA).

Eli Lilly’s drug is now the third of its kind to hit the market, following Leqembi and an ill-fated treatment called Aduhelm from Biogen and Eisai. The two companies recently abandoned the drug. The FDA has been criticized for accelerating approval of Aduhelm in 2021 despite negative recommendations from an advisory panel.