Biologics

AbbVie sBLA for Skyrizi in Crohn’s

AbbVie has submitted a supplemental BLA for Skyrizi (risankizumab) 1,200 mg intravenous (IV) (induction dose) and 180 mg and 360 mg subcutaneous (maintenance doses) for treating adults with moderately to severely active ulcerative colitis. Currently, the drug is approved for treating plaque psoriasis, psoriatic arthritis and Crohn’s disease.

Skyrizi is an interleukin-23 (IL-23) inhibitor that selectively blocks IL-23 by binding to its p19 subunit, according to AbbVie. “IL-23, a cytokine involved in inflammatory processes, is thought to be linked to a number of chronic immune-mediated diseases,” it says.

The submission is based on data from two Phase 3 clinical trials: an induction study, INSPIRE, and a maintenance study, COMMAND. “Significantly more patients treated with risankizumab 1200 mg IV at week 12 in the induction study and 180 mg or 360 mg SC at week 52 in the maintenance study achieved the primary endpoint of clinical remission (per Adapted Mayo Score), compared to patients receiving placebo,” the company says. “Additionally, more risankizumab-treated patients in both the induction and maintenance studies achieved the key secondary endpoints of endoscopic improvement… and histologic endoscopic mucosal improvement compared to placebo,” it adds.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome