Drugs

Supernus Wins OK for Parkinson’s Drug

FDA has approved a Supernus Pharmaceuticals NDA for Onapgo (apomorphine hydrochloride) injection as the first subcutaneous apomorphine infusion device for treating motor fluctuations in adults with advanced Parkinson’s disease. The approval follows two previous complete response letters seeking additional information from the company.

In 4/2024, FDA issued its latest complete response letter that requested more information about product quality and the master file for the infusion device (see earlier story). The first complete response letter was issued in 10/2022, which sought “additional information and analysis related to the infusion device and drug product across several areas of the NDA including, but not limited to, labeling, product quality and manufacturing, device performance and risk analysis,” the company said at the time. The agency also said that before an approval could be granted, inspections were needed because they could not be completed in a timely manner due to Covid-19 travel restrictions.

Approval was based on data from a Phase 3 placebo-controlled study (N=107) evaluating the efficacy and safety of Onapgo, according to Supernus. The primary efficacy endpoint was the mean change in total daily OFF time assessed from baseline to the end of the 12-week treatment period based on patient diaries, it says. The key secondary endpoints were the mean change in daily “good ON time,” which was defined as ON time without troublesome dyskinesia.

During the study, Onapgo was shown to significantly reduce the amount of daily OFF time, with Onapgo-treated patients (N=53) experiencing a 2.6-hour reduction compared to placebo (N=51) with 0.9 hours, the company says. “The reduction in daily OFF time was accompanied by a similar significant increase in daily good ON time (2.8 hours for Onapgo-treated patients compared to 1.1 hours for the placebo group; p=0.0188),” it 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