Drugs

Janssen NDA for Treatment-resistant Depression

Janssen has submitted an NDA for esketamine nasal spray, indicated for treatment-resistant depression in adults. The company says the investigational, rapidly acting antidepressant works differently than currently available therapies for major depressive disorder. “Through glutamate receptor modulation, esketamine is thought to help restore connections between brain cells in people with treatment-resistant depression,” it says.

The submission is based on data from five pivotal Phase 3 studies — three short-term studies, one withdrawal maintenance of effect study, and one long-term safety study. Data demonstrate that treatment with esketamine nasal spray plus a newly initiated oral antidepressant compared to placebo nasal spray plus a newly initiated antidepressant was associated with rapid reduction of depressive symptoms and delayed time to relapse in symptoms, Janssen says. “The long-term safety study showed that the esketamine doses studied were generally tolerated, with no new safety signals with dosing up to 52 weeks, compared to data from the short-term esketamine studies.”

FDA granted the therapy a breakthrough therapy designation for treatment-resistant depression and for a second indication, major depressive disorder with imminent risk for suicide. Janssen says it is currently conducting Phase 3 clinical studies for the second indication.

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