Drugs

Panel Backs Epinephrine Nasal Spray

FDA’s Pulmonary-Allergy Drug Advisory Committee 5/11 voted to recommend approval for ARS Pharmaceuticals’ neffy (epinephrine) nasal spray for treating severe allergic reactions in adults and children. If approved, neffy would become the first needle-free epinephrine product. Panel members voted 16 to 6 to back approval for the nasal spray in adults, and 17 to 5 to recommend its use in children.

Panel members voting to recommend approval seemed to reconcile concerns raised in an FDA briefing document that questioned whether the applicant’s use of pharmacokinetic/pharmacodynamic (PK/PD) data comparing neffy to approved epinephrine injection products and human factor (HF) studies is sufficient to establish a benefit/risk assessment without clinical trials. “The use of epinephrine injection for the treatment of anaphylaxis is based on historical and anecdotal use,” the document says. “Adequate and well-controlled clinical trials have not been conducted. Given feasibility constraints of conducting clinical efficacy trials for the anaphylaxis indication, the ARS-1 development program consists of PK/PD and HF [human factors] studies.”

Summarizing the voting results, panel chairman and University of Washington professor David H. Au said that for those voting to support approval “there was confidence in the PK PD data in terms of its translation and its relation to currently existing products.” He said panel members acknowledged that there are risks associated with using the epi pen too, and that does not just relate to physical trauma but emotional trauma as well for patients and family members, which should be taken into consideration. For those voting against approval, Au said most were concerned with “the lack of efficacy data and even a smaller dataset from which to extrapolate.”

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