Drugs

FDA OKs Pfizer Ulcerative Colitis Drug

FDA has approved a Pfizer NDA for Velsipity (etrasimod), an oral, once-daily, selective sphingosine-1-phosphate receptor modulator for adults with moderately to severely active ulcerative colitis (UC). “Velsipity provides adults living with moderately to severely active UC the opportunity to achieve steroid-free remission with an oral, once-daily pill that has a favorable benefit-risk profile,” the company says.

Approval was based on data from the ELEVATE UC Phase 3 program (ELEVATE UC 52 and ELEVATE UC 12) that evaluated the safety and efficacy of Velsipity 2 mg once-daily on clinical remission in UC patients who did not improve on a previous conventional, biologic, or Janus kinase inhibitor therapy, Pfizer says. “Both studies achieved all primary and key secondary efficacy endpoints, with a favorable safety profile consistent with previous studies of Velsipity,” it says.

Specifically, the data showed that clinical remission was 27.0% for patients receiving Velsipity compared to 7.0% for patients receiving placebo at Week 12, and 32.0% compared to 7.0% at Week 52, Pfizer says. “In ELEVATE UC 12, clinical remission was achieved among 26.0% of patients receiving Velsipity compared to 15.0% of patients receiving 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