Drugs

Expanded Use for Vraylar in Schizophrenia Approved

FDA has approved an Allergan supplemental NDA for Vraylar (cariprazine) for the maintenance treatment of adults with schizophrenia. Vraylar was previously approved for the acute treatment of schizophrenia and acute treatment of manic or mixed episodes of Bipolar I disorder in adults. Without maintenance treatment, 60 to 71% of schizophrenia patients relapse within one year, according to the company.

Approval was based on data from a 72-week, multinational, double-blind, placebo-controlled, randomized withdrawal study in the prevention of relapse in adult patients with schizophrenia. “The study demonstrated that Vraylar significantly delayed the time to relapse compared to placebo (P=0.0010),” Allergan says. Relapse occurred in nearly twice as many placebo-treated patients as Vraylar-treated patients, it adds.

Allergan says that safety results were consistent with the profile observed to-date for Vraylar. Adverse reactions have included rash, pruritus, urticaria, and events suggestive of angioedema.

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