Drugs

Clinical Hold on RAPT Zelnecirnon Studies

FDA has placed a clinical hold on a RAPT Therapeutics Phase 2b trial of zelnecirnon (RPT193) in atopic dermatitis and a Phase 2a trial in asthma. The action was based on a serious adverse event — liver failure — in one patient in the atopic dermatitis trial, according to the company. The adverse event cause is currently unknown but it has been characterized as potentially related to zelnecirnon, it says, adding that dosing and new patient enrollment has been halted in both trials. It notes that the clinical hold does not apply to RAPT’s ongoing trial of tivumecirnon (FLX475) in oncology.

“A total of approximately 350 patients have been enrolled across three trials evaluating zelnecirnon — the two Phase 2 trials and an earlier Phase 1a/1b study,” RAPT says. “No evidence of liver toxicity has been observed with any other trial participant. Additionally, no evidence of liver toxicity was observed in nonclinical studies.”

Additionally, the company says it is undertaking a thorough investigation of the case, which involved a patient with a “complex medical history, including a history of drug allergy to dupilumab, autoimmune disease resulting in thyroid hormone replacement therapy and use of an herbal supplement known to be associated with liver failure, as well as a reported Covid-19 infection during the time of the event.”

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