Drugs

Fabre-Kramer Resubmits Depression Drug NDA

FDA has accepted for review a Fabre-Kramer Pharmaceuticals NDA resubmission for Exxua (gepirone HCl) extended-release tablets, novel serotonin (5HT) single receptor (1A) agonist that has demonstrated effectiveness and a favorable safety profile in clinical trials as monotherapy for major depressive disorder.

This is the fourth attempt to get gepirone approved since 2001 when Organon submitted an NDA under the trade name Ariza (gepirone ER tablets). In 2002, the submission was rejected due to efficacy concerns. In 2007, Fabre-Kramer and GlaxoSmithKline received a not-approvable letter that asked for an additional positive short-term trial as confirmatory evidence of efficacy. In 2016, FDA rejected the drug after FDA’s Psychopharmacologic Drugs Advisory Committee voted 9 to 13 to not recommend approval. Most panel members said the data did not support a favorable benefit-risk profile for treating MDD.

After the last rejection in 2016, Fabre-Kramer filed an appeal to FDA’s Office of New Drugs (OND), which concluded that its then-named Travivo (gepirone) demonstrated substantial evidence of effectiveness in treating major depressive disorder, and thereby overturning the agency’s previous position reached at a lower level. According to the company, then-OND director John Jenkins stated that in reaching his decision, he considered company-submitted materials, its two trials with effect sizes similar to already approved antidepressants, and consultations with staff including CDER Director of the Division of Biostatistics, Lisa LaVange.

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