Drugs

Sun Pharma NDA for Alopecia Areata

FDA has accepted for review a Sun Pharmaceutical Industries NDA for deuruxolitinib, an investigational oral selective inhibitor of Janus kinases JAK1 and JAK2 for treating adults with moderate to severe alopecia areata. The submission is based on data from two pivotal Phase 3 trials (THRIVE-AA1 and THRIVE-AA2), which included over 1,200 patients across more than 135 clinical trial sites.

“Significant differences in achieving the clinically-meaningful SALT score less than or equal to 20 for the treatment arm compared to placebo were seen as early as Week 8 and were maintained throughout the studies,” the company says. The Severity of Alopecia Tool (SALT) evaluates hair loss by scalp quadrant and assigns a score using the weighted sum of percentage of hair loss in the four scalp quadrants (SALT score of 0 means no hair loss, while a SALT score of 100 is total hair loss).

Sun says that treatment with deuruxolitinib was generally well-tolerated and patient satisfaction was significantly higher for the 8 (XXX INSERT SPACE XXX)mg dose compared with placebo.

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