Drugs

FDA Rejects sNDA for Rexulti’s Use in PTSD

FDA has rejected Otsuka Pharmaceutical and H. Lundbeck’s bid to expand the use of Rexulti (brexpiprazole) for treating post-traumatic stress disorder in adults. An agency-issued complete response letter said the application, which sought approval for Rexulti in combination with the antidepressant sertraline (Zoloft), did not provide “substantial evidence of effectiveness” to support approval, according to the companies.

The decision follows a 7/18 meeting of the Psychopharmacologic Drugs Advisory Committee, where panelists voted 10-1 against approving the combination treatment based on the efficacy data submitted. An agency briefing document released before the meeting saw medical reviewers citing inconsistent trial results and a modest treatment effect that they wrote may not be clinically meaningful as reasons for raising efficacy concerns.

Rexulti is currently approved by FDA for treating agitation in patients with Alzheimer’s disease and for adults with major depressive disorder and schizophrenia.

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