Drugs

Janssen NDA for Pediatric Use Xalrelto

Janssen Pharmaceutical has submitted an NDA for Xarelto (rivaroxaban) and its use in pediatric patients. The company says the NDA seeks two pediatric indications: treatment of venous thromboembolism (VTE) and reduction in the risk of recurrent VTE in patients less than 18 years of age after at least five days of initial parenteral anticoagulant treatment; and thromboprophylaxis in patients aged two years and older with congenital heart disease who have undergone the Fontan procedure. If approved, Xarelto would be the first oral Factor Xa inhibitor indicated in the U.S. for use in pediatric patients, it says.

The submission is based on data from two Phase 3 clinical trials in pediatric populations: EINSTEIN-Jr, which examined pediatric patients with previously diagnosed VTE, and UNIVERSE, which evaluated pediatric patients who are at risk of VTE after recently undergoing the Fontan procedure.

Xarelto was originally approved in 2011 to reduce the risk of stroke and blood clots in people who have atrial fibrillation that is not caused by a heart valve problem.

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