Drugs

FDA Approves Takeda’s Orzeyful for Narcolepsy Type 1

FDA has approved Takeda’s Orzeyful (oveporexton) tablets to treat narcolepsy type 1 in adults. An agency statement says Orzeyful is the first medicine approved for narcolepsy type 1 as a complete disorder, addressing the full range of symptoms that define the condition. It is the first drug to work by directly targeting the loss of orexin signaling that causes the disease, FDA says.

The statement says the safety and efficacy of Orzeyful were evaluated in two 12-week studies that enrolled 273 adults with narcolepsy type 1. It says that in both studies, patients taking Orzeyful 2 mg showed improvements in their ability to stay awake during the day compared with those receiving a placebo. Patients also reported substantially less daytime sleepiness, a significant reduction in cataplexy episodes, and meaningful improvement across the full range of narcolepsy symptoms, including sleep paralysis, hallucinations, and disrupted nighttime sleep.

The most common side effects were reported to be insomnia, increased urinary frequency, urgency to urinate, and increased saliva production.

FDA granted Orzeyful Breakthrough Therapy and Priority Review designations.

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

Read more

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