Biologics

Genentech Xolair sBLA Accepted for Pediatric Use

FDA has accepted for review a Genentech supplemental BLA for an expanded indication for Xolair (omalizumab) in pediatric patients with allergic asthma. The review will evaluate Xolair’s use in children aged six through 11 years for treating moderate to severe persistent asthma in those patients with a positive skin test or in vitro reactivity to a perennial aeroallergen (airborne allergen) and symptoms that are inadequately controlled with inhaled corticosteroids. Xolair was approved in 2003 for moderate to severe persistent asthma in patients 12 years of age and above. In 2014, the agency approved its use to treat adults and children 12 years of age and older with chronic idiopathic urticaria.

The submission is supported by multi-center, randomized, double-blind, placebo-controlled Phase 3 studies. The primary study is a 52-week trial, with the primary endpoint measured at 24 weeks, which showed omalizumab reducing the rate of clinically significant asthma exacerbations by 31% versus placebo, according to the company. Over 52 weeks, the exacerbation rate was reduced by 43% versus placebo (P < .001).

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