Drugs

FDA OKs 3 New Indications for Bimzelx

FDA has approved UCB’s Bimzelx (bimekizumab-bkzx) for treating adults with active psoriatic arthritis (PsA), adults with active non-radiographic axial spondyloarthritis (nr-axSpA) with objective signs of inflammation, and adults with active ankylosing spondylitis (AS). The therapy is designed to selectively inhibit two key cytokines driving inflammatory processes — interleukin 17A (IL-17A) and interleukin 17F (IL-17F). Bimzelx was originally approved 10/2023 for treating moderate-to-severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy.

The indication for active PsA was approved based on data from the Phase 3 BE OPTIMAL and BE COMPLETE studies, in which bimekizumab-bkzx “met the primary endpoint of American College of Rheumatology 50 (ACR50) response at Week 16 versus placebo, and all ranked secondary endpoints,” the company says. The approvals for active nr-axSpA with objective signs of inflammation and active AS are based on data from the Phase 3 BE MOBILE 1 and BE MOBILE 2 studies, respectively. “In both studies, bimekizumab-bkzx met the primary endpoint of Assessment of SpondyloArthritis international Society 40 (ASAS40) response at Week 16 compared with placebo, and all ranked secondary endpoints,” it says.

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