Drugs

Joint Panel Backs Alkermes’ Antipsychotic

FDA’s Psychopharmacologic Drugs Advisory Committee and its Drug Safety and Risk Management Advisory Committee have voted to support approval of an Alkermes NDA for ALKS 3831 (olanzapine/samidorphan), an oral atypical antipsychotic drug candidate for treating adults with schizophrenia and for treating adults with bipolar 1 disorder. The committees also jointly voted that ALKS 3831 meaningfully mitigates olanzapine-associated weight gain (16 yes, 1 no) and that its safety profile has been adequately characterized (13 yes, 3 no, 1 abstention).

Additionally, panel members voted (11 yes, 6 no) that labeling is sufficient to mitigate the risks related to samidorphan’s opioid antagonist action. Alkermes’ says its proposed labeling contraindicates the drug’s use in patients who are opioid-dependent or chronically using opioids, and the company has proposed a comprehensive education plan, which includes dissemination of information to potential prescribers and pharmacists.

Alkermes’s NDA submission is based on data from 27 clinical studies, including 18 studies evaluating ALKS 3831 and nine studies evaluating samidorphan alone. The drug user fee review action target date is 11/15.

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