Drugs

Lilly NDA for Migraine; Plans sBLA for Cluster Headaches

Eli Lilly has submitted an NDA for lasmiditan for the acute treatment of migraine with or without aura in adults. The company describes the centrally-penetrant, selective serotonin 5-HT1F agonist as “structurally and mechanistically distinct from other approved migraine therapies and lacks vasoconstrictive activity.”

The NDA includes data from two Phase 3 single-attack studies (SAMURAI and SPARTAN). “In both studies, at two hours following the first dose of lasmiditan, the percentage of patients who were migraine pain-free was significantly greater compared to placebo,” the company says. The results were significant across all studied doses. Lasmiditan also met the key secondary endpoint, with a significantly greater percentage of patients free of their most bothersome symptom (sensitivity to light, sensitivity to sound or nausea) compared with placebo at two hours following the first dose. Lilly says that the most commonly reported adverse events after lasmiditan dosing were dizziness, paresthesia, somnolence, fatigue, nausea, muscle weakness and numbness.

Additionally, Lilly plans to submit a supplemental BLA for Emgality (galcanezumab-gnlm) for preventing episodic cluster headache in adults by the end of the year. The agency has granted it a breakthrough therapy designation. Emgality was approved by FDA in September for preventing migraine headaches in adults. Currently, there are no approved preventive treatments for episodic cluster headache in the U.S.

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