Drugs

AbbVie NDA for Migraine Accepted for Review

FDA has accepted for review an AbbVie NDA for atogepant, an orally administered calcitonin gene-related peptide receptor antagonist for the preventive treatment of migraine in adults who meet criteria for episodic migraine. The company says it expects a regulatory decision late in the third quarter.

The submission is based on data from a pivotal Phase 3 study called ADVANCE, a pivotal Phase 2b/3 study, and a Phase 3 long-term safety study. In the Phase 3 ADVANCE study, all atogepant active treatment arms met their primary endpoint of a statistically significant reduction in mean monthly migraine days over a 12-week treatment period, AbbVie says. Also, the 30 and 60 mg doses met all six secondary endpoints with statistical significance, it says. The study results were announced 7/2020.

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