Drugs

FDA, Mezzion Pharma Agree to Special Protocol Assessment

FDA and Mezzion Pharma Co. have come to terms on a special protocol assessment (SPA) for two Phase 3 clinical protocols for the company’s extended half-life phosphodiesterase type 5 inhibitor (PDE5i) udenafil and its use in adolescents with single ventricle congenital heart disease with Fontan physiology. Previously, the agency designated udenafil as an orphan drug, and it is estimated that about 29,000 patients in the U.S. with this condition.

The protocols were developed by a subcommittee made up of representatives of the Pediatric Heart Network, a multi-center clinical research network funded by NIH’s National Heart, Lung, and Blood Institute. The studies are designed to assess the improvement in certain acute and chronic symptoms associated with single ventricle congenital heart disease with Fontan physiology, according to the company. “The Fontan procedure is the final surgery in a series of palliative surgical operations in children born with single ventricle congenital heart disease,” it says. “Fontan patients have a significantly shortened life span, often not surviving past the third or fourth decade of life, due to deteriorating ventricular performance, increasing pulmonary vascular resistance and associated secondary pathologies.”

PDE5 inhibitors have demonstrated their ability to reduce pulmonary vascular resistance and improve ventricular performance in other types of patients, according to the company. “Those characteristics make PDE5 inhibitors, especially a long-acting compound such as udenafil, potentially attractive as a long-term interventional therapy in that segment of the Fontan population that is still relatively unimpaired by the disease,” it 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

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