Drugs

Complete Response Issued on Minerva Schizophrenia Drug

FDA has issued Minerva Neurosciences a complete response letter on its NDA for roluperidone, indicated for treating negative symptoms in patients with schizophrenia, recommending another clinical study to demonstrate the drug’s safety and effectiveness.

The company says the agency letter cited the submission’s study (MIN-101C03) as being “insufficient on its own to establish substantial evidence of effectiveness.” It also cited a lack of data on “concomitant antipsychotic administration,” and a lack of data to support reliance of a change in negative symptoms of schizophrenia as being clinically meaningful. Additionally, the agency said the submitted safety database included an inadequate number of subjects exposed to roluperidone at the proposed dose (64 mg) for at least 12 months, according to the company.

“We are disappointed that the FDA has not approved roluperidone and will request a meeting to discuss the issues raised and attempt to address FDA’s feedback,” Minerva said in a release.

Minerva says toluperidone has been shown to block serotonin, sigma and α-adrenergic receptors that are all involved in regulating key brain functions, including mood, cognition, sleep, and anxiety. It was designed to “avoid a direct blockade of dopaminergic receptors (the key pharmacological target for first- and second-generation antipsychotics)…,” it adds.

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