Drugs

Sunovion NDA for Binge Eating Disorder Submitted

FDA has accepted for review a Sunovion Pharmaceuticals NDA for dasotraline, a novel dopamine and norepinephrine reuptake inhibitor for treating patients with moderate-to-severe binge eating disorder (BED). The agency has set a 5/14/2020 review action target date.

The submission is based on data from two 12-week, randomized, placebo-controlled studies, SEP360-221 and SEP360-321 that found dasotraline to be generally well tolerated, according to the company. It also includes data from a long-term safety study, SEP360-322, that assessed patients with moderate-to-severe BED for up to one year.

Dasotraline is a new chemical entity that inhibits presynaptic reuptake of dopamine and norepinephrine in the central nervous system, Sunovion says, adding that it does not stimulate neuronal release of dopamine and norepinephrine. “Dasotraline’s pharmacokinetic profile, characterized by an extended half-life, supports its potential for sustained control of moderate-to-severe BED symptoms,” 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

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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