Drugs

Axsome Therapeutics Gets FDA Inspection Confirmation

FDA has told Axsome Therapeutics that it will now meet its inspection deadline on inspecting the company’s contract manufacturing facility related to a 9/2021-submitted NDA for AXS-07 (meloxicam-rizatriptan) for the acute treatment of migraine. Previously, the agency had notified Axsome that due to Covid-19 pandemic-related travel restrictions the inspection could be delayed, which could impact a review decision before the user fee review action target date of 4/30. The agency restarted domestic inspections 2/7 in response to declining Covid cases across the country.

The NDA is supported by data from two Phase 3 randomized, double-blind, controlled trials, MOMENTUM and INTERCEPT, which the company says demonstrated statistically significant elimination of migraine pain compared to placebo and active controls. Axsome describes AXS-07 as an oral, rapidly absorbed, multi-mechanistic drug comprising meloxicam and rizatriptan. Meloxicam is a COX-2 preferential non-steroidal anti-inflammatory drug that is enabled by Axsome’s Molecular Solubility Enhanced Inclusion Complex technology to allow rapid absorption while maintaining a long plasma half-life, the company says. Rizatriptan belongs to the triptan drug class that has been used for many years in treating migraines.

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