Drugs

Incyte Review Extension on Opzelura Cream

FDA has extened by three months its review of Incyte’s supplemental NDA for Opzelura (ruxolitinib) cream for treating vitiligo. The new user fee review action target date is 7/18. The review extension is intended to provide FDA needed time to review additional data from ongoing Phase 3 studies submitted by Incyte in response to an agency information request. The new data submission was determined to be a major amendment. “The pivotal Phase 3 TRuE-V clinical trial program (TRuE-V1 and TRuE-V2) is evaluating the safety and efficacy of ruxolitinib cream versus vehicle in more than 600 adolescent and adult patients (age 12 and older) with non-segmental vitiligo,” the company says.

Ruxolitinib cream (Opzelura) is described as a novel formulation of Incyte’s selective JAK1/JAK2 inhibitor ruxolitinib, which Incyte says is the only topical JAK inhibitor approved for use in the U.S. for the topical short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis in non-immunocompromised patients 12 years of age and older whose disease is not adequately controlled with topical prescription therapies, or when those therapies are not advisable.

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

Read more

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