Drugs

Correvio Pharma NDA Again Rejected Over Safety Concerns

FDA has again issued Correvio Pharma a complete response letter on its NDA for Brinavess (vernakalant IV), an anti-arrhythmic drug for converting atrial fibrillation, due to safety concerns. The agency letter provided recommendations needed for resubmission, according to the company. “FDA stated that while the submitted data provides substantial evidence of Brinavess’ effectiveness, the data do not provide reassuring evidence of Brinavess’ safety,” Correvio says.

Additionally, the company was told that it will “need to develop an approach to select patients who are at low risk of adverse cardiovascular reactions and that data from an additional, potentially uncontrolled, clinical study will be needed to assess Brinavess’ cardiovascular risk in the selected patient population and to support an NDA resubmission,” the company says. The agency added that the risk of serious cardiovascular adverse reactions will need to be much less than 1% in the selected patient population. Correvio says it intends to request a meeting with FDA to discuss the design and specifics of a potential study to address the concerns.

Last month, FDA’s Cardiovascular and Renal Drug Advisory Committee voted 11-2 against recommending the drug’s approval. Panel members were concerned about safety issues, which included bradycardia, ventricular arrhythmias and deaths recorded in clinical trials. This was the second application submission for the drug since 2006, when safety concerns caused the agency to reject the original NDA. A 2010-issued clinical hold remains in effect after the death of a patient involved in an earlier clinical trial that sought data to shore-up a planned resubmission.

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