Lilly Does Not Expect A Quick Medicare Coverage Decision For Donanemab

Eli Lilly and Company may achieve a landmark drug approval early in 2023 when the US Food and Drug Administration decides whether to grant accelerated approval for its anti-amyloid antibody donanemab in the treatment of early Alzheimer’s disease. But as the company outlined its financial guidance for next year, executives were careful to note that despite the sales potential for what may be a disease-modifying AD therapy, donanemab is not expected to generate significant revenue in 2023.

The biggest hurdle to commercial success in the US for the product – and for Eisai Co., Ltd./Biogen, Inc.’s competing therapy lecanemab, which is due to receive an FDA decision on accelerated approval by 6 January – is Medicare coverage