Drugs

Teva Resubmits NDA for Huntington’s Drug

Teva Pharmaceutical Industries has resubmitted an NDA for SD-809 (deutetrabenazine) for treating chorea associated with Huntington disease. The agency has set a user fee review target date of 4/3/2017.

In June, FDA issued Teva a Complete Response Letter on the original submission, asking that it examine blood levels of certain metabolites. “These metabolites are not novel, and are the same seen in subjects who take tetrabenazine or deutetrabenazine,” the company said at the time, adding that no new clinical trials had been requested.

Teva says it is continuing development programs involving SD-809 and its use in treating patients with tardive dyskinesia and Tourette syndrome. The company is currently conducting a Phase 3 efficacy and safety study in patients with moderate to severe tardive dyskinesia known as AIM-TD (Addressing Involuntary Movements in Tardive Dyskinesia) and expects additional data from this study later in 2016, followed by a regulatory submission shortly thereafter. SD-809 has also been granted orphan drug designation for treating Tourette’s in the pediatric population, it says, adding that a study is being planned for treating tics associated with the condition.

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