Drugs

Panel Backs Sage Postpartum Depression Drug

FDA’s Psychopharmacologic Drugs Advisory Committee and Drug Safety and Risk Management Advisory Committee has voted 17 to 1 that data support the benefit-risk profile of Sage’s Zulresso (brexanolone) injection for treating postpartum depression (PPD). Panel members recommended that the drug be administered by qualified staff in a facility that has been certified under a Risk Evaluation and Mitigation Strategies program. If approved, Zulresso would be the first drug specifically for treating PPD.

The REMS program was also recommended by FDA reviewers in a briefing document released before the meeting. The agency’s major safety concern was a loss of consciousness/pre-syncope(LOC) during the infusion (6 of 140 women exposed to brexanolone). “After examining dose, timing of dose, blood level, concurrent medications, available medical history, and patient characteristics (e.g., age, body mass index) we observed no relationships of these variables to LOC events,” the reviewers said. “Because LOC can be abrupt, and there is no way to predict the event, the agency did not feel the risk could be mitigated solely through labeling.”

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