Drugs

Idorsia NDA for Insomnia Drug

FDA has accepted for review an Idorsia NDA for its investigational dual orexin receptor antagonist, daridorexant, for treating adult patients with insomnia. The submission includes data from the company’s Phase 3 registration program, which the company says showed that daridorexant demonstrated statistically significant and clinically meaningful improvements in sleep during the night and, for the first time for an insomnia treatment, in daytime functioning, which were sustained over time.

The company says adverse reactions reported with a frequency greater than 2% in daridorexant-treated patients were headache, somnolence, fatigue, dizziness, and nausea. Patients reported no next-morning sleepiness compared to placebo as assessed by the morning visual analog scale, Idorsa says. “These results make daridorexant the first sleep medication to demonstrate an improvement in sleep and daytime functioning, as measured by a newly developed and validated instrument, while keeping a favorable safety profile in adult and elderly patients,” it says.

Daridorexant is a dual orexin receptor antagonist that is designed to reduce overactive wakefulness associated with insomnia by blocking the activity of orexin. Idorsia says its research team designed the drug to have a rapid onset of effect and a duration of action sufficient to cover the night but short enough to avoid any negative next-morning residual activity.

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