Drugs

FDA to Review Iveric NDA for Avacincaptad Pegol

FDA has accepted an Iveric Bio NDA for avacincaptad pegol, described as a novel investigational complement CS inhibitor for treating geographic atrophy secondary to age-related macular degeneration. The company says the PDUFA action date on the NDA is 8/19. The agency granted priority review of the NDA.

Iveric says it has been advised that at this time FDA has not identified any potential review issues and is not planning to convene an advisory committee to consider the NDA.

The submission is based on the 12-month pre-specified primary efficacy and safety results from the GATHER1 and GATHER2 clinical trials, the company says.

Iveric says avacincaptad pegol is the only investigational product to treat geographic atrophy to achieve the pre-specified 12-month primary endpoint in two Phase 3 pivotal trials with observed efficacy rates of up to 35%. It also is the only investigational therapy to receive FDA’s Breakthrough Therapy designation for geographic atrophy secondary to age-related macular degeneration, Iveric says.

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