Drugs

Vertex Reports Positive Interim Phase 3 Data for Povetacicept

Vertex Pharmaceuticals says an interim analysis of its Phase 3 RAINIER trial showed its experimental therapy povetacicept significantly reduced proteinuria and improved other disease markers in adults with IgA nephropathy, positioning the drug candidate for a potential U.S. accelerated approval filing this month. At 36 weeks, patients treated with povetacicept achieved a 52% reduction from baseline in proteinuria, measured by the 24-hour urine protein-to-creatinine ratio (UPCR), compared with a 4.3% reduction in the placebo group, the company says. This translated into a placebo-adjusted reduction of 49.8%, a statistically significant result that met the trial’s primary endpoint.

The study also met both secondary endpoints, according to the company. Treatment with povetacicept reduced serum galactose-deficient IgA1 (Gd-IgA1) — a biomarker associated with disease activity — by 77.4% from baseline, compared with a 9.1% increase in the placebo group. The placebo-adjusted reduction was 79.3%.

Among patients who had blood in their urine at baseline, 85.1% of those receiving povetacicept experienced hematuria resolution compared with 23.4% of patients receiving placebo, the company adds.

Povetacicept was generally safe and well tolerated, according to the company. Most adverse events were mild to moderate, and no deaths or drug-related serious adverse events were reported in the trial. Serious adverse events occurred in 3.0% of patients treated with povetacicept compared with 4.3% in the placebo arm.

Vertex says it has already begun submitting portions of a BLA to FDA, and it plans to complete the submission by the end of the month, seeking accelerated approval for the drug. The company intends to use a priority review voucher that could shorten the FDA review timeline from 10 months to six months.

If approved, the therapy would be delivered through a low-volume auto-injector designed for once-monthly at-home administration.

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