June 17 Quick Takes: Skyrizi gains first IBD approval

AbbVie Inc. (NYSE:ABBV) said FDA approved Skyrizi risankizumab to treat moderate-to-severe Crohn’s disease, building on prior approvals for psoriasis and psoriatic arthritis. AbbVie has estimated that approvals in irritable bowel disease indications, including Crohn’s and ulcerative colitis, could deliver about $1.5 billion in 2025 sales of the humanized IgG1 mAb that binds and neutralizes the p19 subunit of IL-23, along with $6 billion from its other indications. The pharma is relying on Skyrizi and another autoimmune drug, Rinvoq upadacitinib, to help offset lost sales of Humira adalimumab after the blockbuster loses patent exclusivity next year.

In a 3-9 vote, the FDA advisory committee convened on Friday did not recommend approval of an sNDA for Nuplazid pimavanserin from Acadia Pharmaceuticals Inc. (NASDAQ:ACAD) to treat hallucinations and delusions associated with Alzheimer’s disease psychosis. Committee members said there were too many issues with efficacy data and that Nuplazid’s prior approval was irrelevant for the new indication, echoing FDA’s conclusion that the data “failed to demonstrate a treatment effect in the AD population.” FDA approved Nuplazid in 2016 to treat hallucinations and delusions associated with Parkinson’s disease psychosis, but issued a complete response letter to Acadia in 2021 related to an application for dementia-related psychosis...