Biologics

FDA Accepts Vanda BLA for Rare Skin Disorder Drug

FDA has accepted for review a Vanda Pharmaceuticals BLA for imsidolimab, a potential new treatment for generalized pustular psoriasis (GPP), a rare and life-threatening autoinflammatory skin disorder. The agency has set a review action target date of 12/12.

GPP is characterized by sudden flares of widespread pustules, red skin, and systemic symptoms such as fever and fatigue, the company says. The disease is linked to excessive activity of the interleukin-36 (IL-36) pathway, with many cases caused by genetic variants in the IL36RN gene.

Imsidolimab is described as a monoclonal antibody designed to inhibit IL-36 receptor signaling. In pivotal clinical trials, including GEMINI-1 and GEMINI-2, a single intravenous dose produced rapid skin clearance, with 53% of patients achieving clear or almost clear skin by Week 4, compared with 13% for placebo, the company says. Long-term treatment maintained disease control over approximately two years, with no flares reported in patients receiving imsidolimab. The drug demonstrated a favorable safety profile and a low incidence of anti-drug antibodies.

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