Drugs

Arca Biopharma Seeks Special Protocol for Heart Failure Trial

Arca Biopharma has submitted a special protocol assessment request for its planned Phase 3 clinical development program of Gencaro (bucindolol hydrochloride) as a genetically-targeted treatment for heart failure patients at risk for atrial fibrillation (AF). The submission details a single adequate and well-controlled Phase 3 clinical trial (PRECISION-AF) designed as a double-blind, active-controlled, multicenter, international study comparing Gencaro with Toprol-XL (metoprolol succinate) for preventing recurrent AF or all-cause mortality, according to the company.

“The primary endpoint of the submitted trial will utilize AF Burden (AFB) methodology,” it says. “AFB is defined as the amount of time per day a patient experienced AF, as measured by an implanted cardiac electronic device (CIED). In the recently completed GENETIC-AF Phase 2 clinical trial, Gencaro showed a trend for 25% benefit over Toprol-XL in reducing AF recurrence as measured by AFB in a subgroup of patients with continuous monitoring with a CIED.”

The proposed trial will also have an adaptive design with an interim analysis and use standard significance criteria (p < 0.05) for the primary endpoint, Arca says. If approved, Arca anticipates beginning PRECISION-AF in the second half of 2019.

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