Biologics

FDA Extends Skyrizi sBLA Review by 3 Months

FDA has extended by three months its review of an AbbVie supplemental BLA for Skyrizi (risankizumab-rzaa) for treating moderate to severe Crohn’s disease in patients 16 years and older. The extension gives the agency additional time to review additional data submitted by AbbVie, including information about the on-body injector, for the new proposed indication.

Skyrizi was approved in the U.S. in 2019 to treat moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. Earlier this year, it was approved to treat active psoriatic arthritis in adults.

The sBLA submission is based on data from three Phase 3 studies — ADVANCE, MOTIVATE and FORTIFY. The company says data from the induction studies ADVANCE and MOTIVATE, showed that a significantly greater proportion of patients with Crohn’s disease treated with either dose of risankizumab-rzaa IV induction therapy (600 mg or 1200 mg) met the co-primary endpoints of clinical remission and endoscopic response at week 12 compared to placebo. In the FORTIFY randomized-withdrawal maintenance trial, a significantly greater proportion of participants achieved endoscopic response and clinical remission with risankizumab-rzaa SC at one year for both assessed doses (360 mg or 180 mg) compared to those who were randomized to the withdrawal arm and received a placebo.

The safety profile, AbbVie says, was generally consistent with the known safety profile of risankizumab-rzaa.

Skyrizi is an interleukin-23 (IL-23) inhibitor that selectively blocks IL-23 by binding to its p19 subunit, AbbVie says, adding that IL-23 is a cytokine involved in inflammatory processes.

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