Drugs

FDA Accepts Takeda’s Oveporexton NDA for Narcolepsy Type 1

FDA has accepted for priority review a Takeda NDA for TAK-861 (oveporexton) as a potential first-in-class treatment for narcolepsy Type 1. Narcolepsy Type 1 is a rare, chronic neurological disorder characterized by excessive daytime sleepiness and cataplexy, resulting from loss of orexin-producing neurons. The agency has set a user fee review action target for the third quarter.

Oveporexton is described as an investigational oral orexin receptor 2 (OX2R)–selective agonist designed to restore orexin signaling, addressing the underlying orexin deficiency that causes narcolepsy Type 1. If approved, it would be the first orexin agonist available for patients with the disease, according to the company.

The submission is based on data from two global Phase 3 studies, FirstLight (TAK-861-3001) and RadiantLight (TAK-861-3002). According to Takeda, the trials demonstrated statistically significant and clinically meaningful improvements across multiple objective and patient-reported endpoints, including wakefulness, excessive daytime sleepiness, cataplexy, attention, quality of life, and daily functioning. Reported improvements approached near-normal ranges across the assessed symptom domains, it adds.

Oveporexton was generally well tolerated, with a safety profile consistent across studies. The most common adverse events reported were insomnia, urinary urgency, and urinary frequency, the company says.

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