Drugs

FDA Approves Neurocrine Parkinson’s Drug

FDA has approved a Neurocrine Biosciences NDA for Ongentys (opicapone) 25 mg and 50 mg capsules as an add-on treatment to levodopa/carbidopa in patients with Parkinson’s disease experiencing “off” episodes. As the disease progresses, patients taking levodopa/carbidopa may begin to experience “off” time between treatment doses where an increase in motor symptoms (tremor, slowed movement and difficulty walking) occur. The company says Ongentys also increases “on” time without troublesome dyskinesia, the time when the motor symptoms of a patient with Parkinson’s disease are better controlled.

Approval is supported by data from 38 clinical studies, including two multinational Phase 3 clinical studies (BIPARK-1 and BIPARK-2), with more than 1,000 Parkinson's disease patients treated with Ongentys, Neurocrine says. . “Data from both trials showed that Ongentys 50 mg significantly reduced “off” time from baseline to week 14 or 15 compared to placebo, it says. “On” time without troublesome dyskinesia also increased from baseline to week 14 or 15 compared to placebo.

Pooled safety data from the BIPARK studies indicated that the most common adverse reactions across all patients treated with Ongentys were dyskinesia, constipation, blood creatine kinase increase, hypotension/syncope and weight decrease.

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