PAA, A New Dawn , FDA ODD Approval and Entering Phase II MND Trial, page-697

I just read this, not sure if it has been posted before

After turning down Eli Lilly’s Alzheimer’s disease drug donanemab for an accelerated approval last year, the agency has now offered the anti-amyloid therapy—and a competitor to Eisai and Biogen’s Leqembi—a full approval.The FDA has cleared donanemab-abzt, branded as Kisunla, to treat adults with early symptomatic Alzheimer’s disease, including people with mild cognitive impairment and those in the mild dementia stage of the neurodegenerative disease, Lilly said Tuesday.Kisunla’s indication is almost identical to the FDA-approved use for Leqembi. Both drugs need confirmation of amyloid beta pathology in patients' brain tissue before beginning treatment, and both bear a boxed warning on the risk of amyloid-related imaging abnormalities (ARIA), which are known side effects of these antibodies that target the toxic aggregates of beta amyloid proteins.But industry watchers believe Lilly’s offering holds at least one advantage, which the company was quick to highlight in its approval announcement. Kisunla is the first anti-amyloid drug that allows for stopping therapy when amyloid plaques are removed, enabling fewer infusions and lower treatment costs.And while Leqembi is given as an intravenous infusion once every two weeks, Kisunla is dosed every four weeks. Lilly has priced Kisunla at a list price of $695.65 per vial. The total cost will depend on when a patient completes treatment. For one year, the Lilly therapy costs $32,000, which is higher than Leqembi’s U.S. launch price of $26,500 per year.The disadvantage of Kisunla, however, is a perceived less favorable safety profile on ARIAs compared with Leqembi. And the drug's FDA label reflects this factor.While Leqembi’s label requires four brain MRI scans before infusions, Kisunla’s demands five. The requirement for the extra MRI scan was expected after Lilly showed that an MRI prior to the second infusion led to a 25% reduction in serious ARIA cases.In a June note to clients, Leerink Partners analysts said they expect Leqembi will grab more market share given its better ARIA profile, but the analysts also said the Alzheimer’s market is large enough for multiple players. Besides, the competitor launch should accelerate the uptake of the entire class by helping build the commercial infrastructure around the medicines, the team added.