Drugs

Roivant Scraps Sarcoidosis Drug After Failed Trial

Roivant says its Kinevant Sciences unit is discontinuing its development of namilumab for treating sarcoidosis after a Phase 2 study failed to show treatment benefit. The Phase 2 RESOLVE-Lung study (NCT05314517) “failed to meet the primary endpoint of proportion of subjects with a rescue event during the double-blind period,” Roivant says. “Secondary efficacy endpoints, including change in percent predicted forced vital capacity, corticosteroid tapering success, and change in the patient-reported King’s Sarcoidosis Questionnaire failed to show a treatment benefit consistent with the primary endpoint,” it adds.

Regarding safety, the company says namilumab’s profile in RESOLVE-Lung remains similar to previous studies. Results of the study will be published at a later date to inform future sarcoidosis research, it says.

Namilumab is described as a granulocyte macrophage colony stimulating factor (GM-CSF). The company says GM-CSF-mediated pro-inflammatory signaling is thought to play a key role in recruitment of macrophages and monocytes to the lung and to trigger a granulomatous response.

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