Drugs

Insmed Halts Brensocatib Program After Mid-Stage Trial Miss

Insmed says it will discontinue development of its drug candidate brensocatib for hidradenitis suppurativa (HS) after a mid-stage clinical trial failed to meet its primary and secondary efficacy endpoints. HS is a chronic, non-contagious inflammatory skin disease characterized by painful lumps (nodules/boils) that form under the skin, usually in the armpits or groin. It causes recurrent abscesses that may rupture, forming tunnels (sinus tracts) and scarring.

The company reports that its Phase 2b CEDAR study, which evaluated brensocatib in adults with moderate to severe hidradenitis suppurativa, did not demonstrate improvement over placebo at either the 10 mg or 40 mg doses.

At 16 weeks, patients receiving brensocatib saw reductions in total abscess and inflammatory nodule counts of 45.5% and 40.3% for the 10 mg and 40 mg arms, respectively. However, the placebo group showed a greater reduction of 57.1%, leading to the study missing its primary endpoint, according to the company.

Despite the lack of efficacy, the company said the treatment was generally well tolerated, with no new safety signals observed across either dose. Rates of treatment-emergent adverse events were comparable across study arms, and serious adverse events remained low.

Insmed said it plans to present detailed results from the study at a future scientific meeting.

The decision narrows the development focus for brensocatib, a dipeptidyl peptidase 1 (DPP1) inhibitor that has been studied in multiple inflammatory conditions.

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