Drugs

Xenon Reports Positive Phase 3 Data for Epilepsy Drug

Xenon Pharmaceuticals says its experimental epilepsy drug azetukalner met the primary endpoint in a late-stage clinical trial in patients with focal onset seizures, paving the way for a planned U.S. regulatory filing later this year. Topline results from the Phase 3 X-TOLE2 study showed the drug significantly reduced seizure frequency compared with placebo when used as an add-on therapy. Patients receiving a 25-mg dose experienced a median 53.2% reduction in monthly seizure frequency from baseline, compared with a 10.4% reduction for placebo, it says. The 15-mg dose achieved a 34.5% reduction.

Xenon plans to submit an NDA in the third quarter seeking approval of azetukalner for focal onset seizures. If approved, the drug would be the only epilepsy treatment that works by opening KV7 potassium channels, a mechanism designed to reduce abnormal electrical activity in the brain, according to the company.

Safety findings were broadly consistent with previous studies, the company says. The most common side effects among patients taking azetukalner included dizziness, headache, somnolence and fatigue. Treatment discontinuations due to adverse events occurred in 14.5% of patients in the 25-mg group, 4.8% in the 15-mg group and 3.2% in the placebo arm.

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