Drugs

Xolair sBLA for Treating Nasal Polyps

FDA has accepted for review a Novartis supplemental BLA for Xolair (omalizumab) for treating nasal polyps in adult patients 18 years of age and older with inadequate response to intranasal corticosteroids. The submission is based on results from the Phase 3 POLYP 1 and POLYP 2 trials, which showed Xolair met both co-primary and multiple secondary endpoints in treating adult patients who have not adequately responded to intranasal corticosteroids, the company says. The co-primary endpoints were change from baseline in nasal polyp score and change from baseline in average daily nasal congestion score at 24 weeks. The safety profile in the trials was consistent with the known safety profile for Xolair, with no new unexpected safety signals identified, it says.

Xolair is an injectable biologic designed to target and block immunoglobulin E. It is currently approved for treating moderate-to-severe persistent allergic asthma in people six years of age and older whose asthma symptoms are not controlled by inhaled corticosteroids. It is also approved for chronic idiopathic urticaria in people 12 years of age and older who continue to have hives that are not controlled by H1 antihistamines.

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

Read more

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