Drugs

FDA Wants More Data on Prader-Willi Drug

FDA has told Soleno Therapeutics that an additional controlled clinical trial will be necessary to support an NDA submission for DCCR (diazoxide choline) extended release tablets for treating Prader-Willi Syndrome (PWS). Late last year, the company met with FDA regarding the potential adequacy of data from previous studies with DCCR to support an NDA. Soleno subsequently submitted additional analyses to the agency from the company’s Phase 3 trial, DESTINY PWS (C601).

“The data analyses showed statistically significant changes for DCCR compared to placebo in the primary and key secondary endpoints,” Soleno says. “Following its review of the data submitted by Soleno, the FDA informed the Company on 3/5/2021 that an additional controlled clinical trial will be necessary to support an NDA submission for DCCR in PWS.

The company says that based on the totality of data generated to date, “we remain confident in DCCR’s potential to address the unmet need for a safe and effective treatment option for PWS patients. We are currently evaluating the appropriate next steps for our DCCR program.”

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