Drugs

Novartis’ Cosentyx OK’d for Adolescents With Hidradenitis Suppurativa

FDA has approved Novartis’ Cosentyx (secukinumab) for treating adolescents aged 12 and older with moderate to severe Hidradenitis Suppurativa, expanding the drug’s use into another pediatric indication. The decision makes Cosentyx the only interleukin-17A inhibitor approved in the U.S. for adolescents with the painful inflammatory skin disorder and represents the first therapy with a differentiated mechanism for the condition in nearly a decade, the company says.

Hidradenitis suppurativa (HS) is a chronic disease marked by recurrent boil-like lesions that can rupture and lead to painful wounds and permanent scarring, according to the company. The condition frequently begins during adolescence and can significantly affect quality of life.

The approved was based on data from adult clinical trials in HS, pharmacokinetic modeling from adult HS and psoriasis studies, and pediatric data from other approved indications. Weight-based dosing in adolescents is expected to produce drug exposure comparable to that seen in adult HS patients, according to Novartis.

The label expansion marks the fourth pediatric indication for Cosentyx. The therapy is already approved for certain children with psoriasis and forms of juvenile arthritis, in addition to multiple adult autoimmune conditions.

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