Summer lull as FDA approves only 2 NMEs in July

FDA approved two new molecular entities in July, putting the total for the first seven months of the year at 23, down from 29 at the same time last year. The pace has picked up a bit in the first half of August, with three more NME approvals bringing the year-to-date total to 26, vs. 31 at this point in 2023.

Kisunla donanemab is the third anti-amyloid mAb FDA has approved to treat Alzheimer’s disease, but the first to start off with full, rather than accelerated, approval, and it’s the only one approved as a limited-duration, rather than chronic, treatment. Eli Lilly and Co. (NYSE:LLY) said it has received a positive opinion from Japan’s Pharmaceutical and Medical Devices Agency and expects regulatory action in Japan and Europe by year-end. EMA’s CHMP recommended against approval of the two other anti-amyloid mAbs approved by FDA...