Eli Lilly’s Alzheimer’s drug approved by US FDA

By Julie Steenhuysen and Mariam Sunny

(Reuters) -The U.S. Food and Drug Administration on Tuesday approved Eli Lilly’s treatment for early-onset Alzheimer’s disease, making it the second therapy to slow the progression of the brain-loss disease that will be available to patients North Americans.

The approval of donanemab, to be sold under the brand name Kisunla, followed recommendations from the agency’s outside experts, who unanimously supported its use in patients with early Alzheimer’s disease, saying the drug’s benefits outweighed its risks.

“This is real progress,” said Joanne Pike of the Alzheimer’s Association. “Having multiple treatment options is the kind of breakthrough we have all been waiting for – all of us who have been touched, even taken by surprise, by this difficult and devastating disease. .”

Like Eisai and Biogen’s rival drug Leqembi, which was approved a year ago, donanemab is designed to eliminate an Alzheimer’s-related protein called amyloid beta from the brain.

A key differentiating factor for donanemab is the drug’s finite dosage, which allows patients to stop treatment when brain scans no longer show amyloid plaques.

Lilly priced its drug at $695.65 per vial, or about $32,000 for 12 months of treatment consisting of 13 infusions. This is slightly higher than Eisai’s Leqembi, which costs $26,500 per year.

BMO analyst Evan Seigerman said the price reflects the fact that patients can stop treatment rather than chronic Leqembi treatment.

“The details of how this will play out in clinical practice are not yet clear, but I think it will save a lot of money and patients will like it a lot more,” said Dr. Erik Musiek, a neurologist at the University of Washington at Barnes-Jewish. Hospital.

“I think this, combined with monthly dosing, will make this an attractive option,” he added.

In Lilly’s large late-stage study, 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 it did with Leqembi, the FDA placed its strongest “boxed” safety warning on donanemab’s prescription label, flagging the risk of potentially dangerous brain swelling and hemorrhage.

One key difference is that donanemab will require five MRI scans to check for side effects, while Leqembi requires four, which could be an advantage for the Eisai drug in centers where such scans are scarce, said Brian Abrahams, an analyst at RBC Capital , in a research note.

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Eisai and Biogen have begun submitting data to the FDA to support approval of a monthly maintenance dose to be administered as an intravenous infusion, as well as a weekly injected version of Leqembi that patients could 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 ages 65 and older. Medicare last year began covering Alzheimer’s drugs that receive standard approval from the FDA.

Morningstar analyst Damien Conover said he expects Lilly’s drug to generate peak annual sales of more than $5 billion and “a market split fairly evenly between donanemab and Biogen’s Leqembi.”

More than 6 million Americans have Alzheimer’s disease, according to the Alzheimer’s Association.

(Reporting by Julie Steenhuysen in Chiccago, Deena Beasley in Los Angeles and Bhanvi Satija and Mariam Sunny in Bengaluru; Editing by Bill Berkrot)