Drugs

Clinical Hold Lifted on Vanda’s Motion Sickness Studies

FDA has lifted a partial clinical hold on one of Vanda Pharmaceuticals’ key tradipitant studies, clearing the company to expand dosing in an ongoing motion-sickness trial. The hold on protocol VP-VLY-686-3403 had previously capped dosing at 90 administrations of tradipitant. The FDA lifted that limitation after conducting an expedited re-review of the program, triggered by Vanda’s formal dispute resolution request. The reassessment was carried out within a collaborative framework the company and the agency established in October, according to Vanda.

In its decision, FDA agreed with Vanda that motion sickness is an acute, self-limiting physiologic response, not a chronic or chronic-intermittent condition, according to the company. As a result, the agency determined that tradipitant’s use for motion sickness should be treated as an acute, event-driven therapy — meaning an additional six-month dog toxicity study was unnecessary and the partial hold could be removed.

The ruling enables Vanda to continue and broaden its clinical development of tradipitant for motion sickness. Meanwhile, the company’s separate NDA for tradipitant as a preventive treatment for motion-induced vomiting remains under FDA review. That application has a user fee review action date of 12/30, placing tradipitant in a position to become the first new pharmacologic therapy for motion sickness in more than 40 years, if approved.

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