Drugs

FDA Refuses to Review Alkermes NDA for Depression Drug

FDA has issued Alkermes a Refusal to File letter on its NDA for New ALKS 5461 (buprenorphine and samidorphan), a once-daily, oral investigational medicine for the adjunctive treatment of major depressive disorder in patients with an inadequate response to standard antidepressant therapies. According to the company, FDA said it was unable to complete a substantive review of the regulatory package, based on insufficient evidence of overall effectiveness for the proposed indication, and that additional well-controlled clinical trials were needed prior to resubmission. In addition, the agency requested a bioavailability study to generate additional bridging data between ALKS 5461 and the reference listed drug, buprenorphine.

In response, Alkermes said it strongly disagreed with FDA’s position and it plans to appeal the decision. The company also intends to seek immediate guidance, including requesting a Type A meeting with the agency, to determine appropriate next steps and any additional information that may be required to resubmit the NDA.

ALKS 5461 acts as an opioid system modulator and represents a novel mechanism of action for the adjunctive treatment of major depressive disorder in patients with an inadequate response to other therapies, Alkermes said.

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