Drugs

Questions Raised on Spravato Approval

As reported by NBC News, Kaiser Health News says FDA’s approval of Janssen’s Spravato (esketamine) raises questions about “how drugmakers can take advantage of shortcuts in the FDA process with the agency’s blessing and maneuver through safety and efficacy reviews to bring a lucrative drug to market.” The online report shows that Janssen got FDA to designate esketamine a breakthrough therapy because it showed the potential to reverse depression rapidly. Breakthrough therapy means there is more frequent input from FDA, the report says.

In the case of esketamine, those discussions between the agency and the company affected the amount and quality of evidence required by FDA for approval, including how many drugs must fail for a patient’s depression to be considered intractable and how many successful clinical trials are needed.

Any such prior agreements, Kaiser Health says, can leave FDA advisory committee members “hamstrung in reaching a verdict.”

The report discusses the advisory committee deliberation on Spravato and reports that some members felt there was insufficient evidence to warrant a recommendation for approval. But FDA had approved the trial design and number of trials needed.

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