Drugs

Janssen Pharma Files 2 sBLAs for Simponi Aria

Janssen Pharmaceutical has submitted two supplemental BLAs for Simponi Aria (golimumab) for treating polyarticular juvenile idiopathic arthritis and juvenile psoriatic arthritis in patients two years of age and older in combination with methotrexate. Juvenile Idiopathic Arthritis (JIA) is a disorder group characterized by arthritis persisting for at least six weeks before the age of 16 years, the company says. About 300,000 children suffer from JIA in the U.S. Juvenile psoriatic arthritis is one of the rarest subtypes of JIA and is characterized by both joint inflammation and skin lesions associated with psoriasis resembling the adult form.

Janssen says the submissions are based on results from the GO-VIVA Phase 3 clinical trial, which was designed to extrapolate data from a pivotal Phase 3 clinical development program for Simponi Aria. “With limited pediatric patients available for clinical trial inclusion, researchers can extrapolate data from adult patient trials to determine the potential efficacy and tolerability of a treatment for the pediatric population,” it says.

Simponi Aria is a human anti-TNF-alpha therapy administered via a 30-minute infusion currently approved for treating adults with moderately to severely active rheumatoid arthritis, active psoriatic arthritis or active ankylosing spondylitis.

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