DEKYAS NEWS World Breaking News and Trusted Source
Related Articles
The U.S. Food and Drug Administration on Tuesday approved Eli Lilly’s treatment for early-stage Alzheimer’s disease, the second therapy to slow the progression of the brain disease to become available to U.S. patients.
The approval for donanemab, which will be sold under the brand name Kisunla, followed recommendations from the agency’s outside experts who unanimously supported its use in patients with early-stage Alzheimer’s disease, saying the drug’s benefits outweighed its risks.
“This is real progress,” said Joanne Pike of the Alzheimer’s Association. “Multiple treatment options are the kind of progress we’ve all been waiting for — all of us who have been touched, even overwhelmed, by this difficult and devastating disease.”
Like Eisai 4523.T and Biogen’s rival BIIB.O drug Leqembi, which was approved a year ago, donanemab is designed to clear an Alzheimer’s-related protein called beta-amyloid from the brain.
A key distinguishing feature of donanemab is the limited dosage of the drug, which allows patients to stop treatment once brain scans no longer show amyloid plaques.
Lilly set the price of the drug at $695.65 per vial, or about $32,000 for a 12-month treatment consisting of 13 infusions. That’s slightly higher than Eisai’s Leqembi, which costs $26,500 a year.
According to BMO analyst Evan Seigerman, the price reflects the fact that patients can stop treatment with Leqembi instead of continuing chronic treatment.
“The details of how this will play out in clinical practice are still unclear, but I think it will save a lot of money and patients will be much better off with it,” said Dr. Erik Musicek, a neurologist at Washington University’s Barnes-Jewish Hospital.
The latest health and medical news, delivered to your inbox every Sunday.
“I think this, combined with the monthly dosing, will be an attractive option,” he added.
In Lilly’s large, late-stage trial, donanemab slowed the progression of memory and thinking problems by 29% compared with a placebo. It also caused brain swelling in almost a quarter of patients and brain bleeding in almost a third, but most cases were mild.
As with Leqembi, the FDA placed the strongest safety warning on donanemab’s prescribing label, highlighting the risk of potentially dangerous brain swelling and bleeding.
One key difference is that donanemab requires five MRI scans to monitor side effects, while Leqembi requires four. That could give Eisai’s drug an advantage in centers where such scans are scarce, RBC Capital analyst Brian Abrahams said in a research note.
Eisai and Biogen have begun submitting data to the FDA to support approval of a monthly maintenance dose administered as an intravenous infusion, as well as a weekly injected version of Leqembi that patients can receive at home.
Lilly’s drug is expected to be used primarily by patients enrolled in the U.S. government’s Medicare health plan for people 65 and older. Medicare last year began covering Alzheimer’s drugs that routinely receive FDA approval.
Morningstar analyst Damien Conover said he expects Lilly’s drug to generate more than $5 billion in annual sales and “a fairly even market split between donanemab and Biogen’s Leqembi.”
According to the Alzheimer’s Association, more than six million Americans have Alzheimer’s disease.
