The FDA Approves Eli Lilly’s Alzheimer’s Drug, Kisunla

Key Takeaways:

• Eli Lilly received FDA approval for a drug to help treat Alzheimer’s on Tuesday after studies showed it could help slow the progress of the disease.
• The treatment, which is called donanemab and will be sold under the brand name Kisunla, is a monthly IV infusion.
• The drug, which faced several obstacles to approval, was delayed as recently as March.

Eli Lilly has received Food and Drug Administration (FDA) approval for its treatment for early symptomatic Alzheimer’s after studies showed that the drug was able to slow the progression of the disease.

The monthly IV infusion, known as donanemab, will be sold under the brand name Kisunla, and cost from roughly $12,500 to nearly $50,000 for treatment cycles of six to 18 months, the company said Tuesday.

Treatment Showed Ability To Slow Progression of Alzheimer’s

Lilly said trials showed that the drug “slowed cognitive and functional decline by up to 35% compared to placebo at 18 months” in a Phase 3 trial, and “reduced participants’ risk of progressing to the next clinical stage of disease by up to 39%.”

“We know these medicines have the greatest potential benefit when people are treated earlier in their disease, and we are working hard in partnership with others to improve detection and diagnosis,” Lilly Neuroscience president Anne White said.

Long Path To Approval

The treatment’s path to approval faced roadblocks including a delay in March and a rejection of the drug in January 2023 over a lack of sufficient data. Last month, an independent panel recommended the FDA approve the drug, which sent the company’s stock price higher.

Kisunla joins the market as one of the few treatments for Alzheimer’s. It will now compete with a treatment from Biogen and Japanese partner Eisai called Leqembi. In its most recent earnings report, Biogen said that global in-market sales of the drug nearly tripled from the prior quarter.

“Today’s approval allows people more options and greater opportunity to have more time,” Alzheimer’s Association Chief Executive Officer (CEO) Dr. Joanne Pike said Tuesday. “Having multiple treatment options is the kind of advancement we’ve all been waiting for—all of us who have been touched, even blindsided, by this difficult and devastating disease.”

Eli Lilly shares initially traded higher Wednesday but reversed course and were down 2% to $888.30 as of 11:11 a.m. ET. Still, they have risen more than 50% year-to-date. Biogen’s shares fell 2.3% to $223.50.

In conclusion, Eli Lilly’s FDA approval for Kisunla marks a significant milestone in the treatment of Alzheimer’s disease. The drug has shown promising results in slowing the progression of the disease and offers new hope for patients and their families. With more treatment options available, there is renewed optimism in the fight against this challenging condition.