Drugs

J&J Wins Monotherapy Use for Spravato

FDA has approved a Johnson & Johnson supplemental NDA for Spravato (esketamine) nasal spray for monotherapy use in treating adults with major depressive disorder who have had an inadequate response to at least two oral antidepressants. Previously, Spravato was approved for combination use with an oral antidepressant for treating adults with treatment-resistant depression and depressive symptoms in adults with major depressive disorder with acute suicidal ideation or behavior.

Spravato is said to work by targeting glutamate, an “excitatory” neurotransmitter in the brain. J&J says that the “mechanism by which esketamine exerts its antidepressant effect is unknown.”

The current approval is based on data from a randomized, placebo-controlled study in which Spravato monotherapy “showed a rapid and superior improvement in Montgomery-Asberg Depression Rating Scale (MADRS) total score vs. placebo,” the company says. “In a post-hoc analysis, Spravato demonstrated numerical improvements across all 10 MADRS items at day 28. At week four, 7.6% of patients taking placebo and 22.5% of patients taking Spravato achieved remission…”

Spravato is dispensed under a Risk Evaluation and Mitigation Strategy program due to risks of “serious adverse outcomes resulting from sedation, dissociation, respiratory depression, abuse, and misuse,” J&J notes.

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