Biologics

J&J Seeks Stelara Expanded Use

Johnson & Johnson has submitted a supplemental BLA seeking to expand the use of its biologic therapy Stelara (ustekinumab) to treat children aged two years and older with moderately to severely active ulcerative colitis (UC). The filing is based on data from the Phase 3 UNIFI Jr study, which evaluated the efficacy, safety, and pharmacokinetics of ustekinumab through 52 weeks in pediatric patients with UC.

Stelara, an interleukin-12 and -23 antagonist, is currently approved for treating adults with moderately to severely active Crohn’s disease and ulcerative colitis, as well as adults and children six years and older with active psoriatic arthritis and moderate to severe plaque psoriasis.

The company notes that it also submitted a similar application earlier this year seeking Stelara’s approval for pediatric Crohn’s disease in patients aged two years and older.

Ulcerative colitis, a chronic inflammatory bowel disease that affects more than one million people in the U.S., is increasingly diagnosed in children, who often experience more severe symptoms than adults, according to the company.

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