Biologics

Tremfya Secures Approval for Ulcerative Colitis

FDA has approved Johnson & Johnson’s Tremfya (guselkumab) for treating adults with moderately to severely active ulcerative colitis (UC). Approval was based on data from the ongoing Phase 2b/3 QUASAR study evaluating Tremfya in adult patients with moderately to severely active UC who experienced an inadequate response or who demonstrated intolerance to conventional therapy, other biologics or JAK inhibitors. The data showed that 50% of patients receiving Tremfya 200 mg subcutaneous (SC) every four weeks and 45% of patients receiving Tremfya 100 mg SC every eight weeks achieved the primary endpoint of clinical remission at Week 44 compared to 19% of placebo-treated patients, according to the company. And 34% (200 mg) and 35% (100 mg) of patients achieved endoscopic remission at one year with Tremfya compared to 15% of those on placebo.

Tremfya is described as a dual-acting monoclonal antibody that blocks IL-23 while also binding to CD64, a receptor on cells that produce IL-23. “IL-23 is a cytokine secreted by activated monocyte/macrophages and dendritic cells that is known to be a driver of immune-mediated diseases including UC,” J&J says.

The therapy was first approved in 2017 for treating adult patients with moderate-to-severe plaque psoriasis and received subsequent approval for adults with active psoriatic arthritis in 2020. A supplemental BLA was submitted in June and is pending review for patients with moderately to severely active Crohn’s disease.

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