Drugs

Janssen Depression Drug Gains Joint Panel Backing

In what many are calling a breakthrough treatment for depression, Janssen Pharmaceutical has moved one step closer to FDA approval after the agency’s Psychopharmacologic Drug Advisory Committee and Drug Safety and Risk Management Advisory Committee 2/12 jointly voted 14 to 2 to support Spravato (esketamine) nasal spray. The fast-acting nasal spray, if approved, would provide the first new mechanism of action in 30 years to treat the debilitating mental illness, the company says.

Panel members said the data showed that Spravato could become a “game changer” for treating depression. They voiced support for its response rates and faster response times compared to current therapies. The company presented data from both a short-term and a long-term Phase 3 study that demonstrated esketamine nasal spray plus a newly initiated oral antidepressant provided statistically significant, clinically meaningful, rapid, and sustained improvement of depressive symptoms.

Esketamine is a close form of the anesthetic ketamine, which has been previously abused as a party drug. Addressing the abuse potential, FDA reviewers said ketamine abuse is relatively uncommon, with just 1.3% of those over age 12 abusing the drug, which is lower than abuse rates for other hallucinogens like ecstasy and LSD.

Additionally, Janssen has proposed a Risk Evaluation and Mitigation Strategy to manage the drug’s risks.

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