Drugs

Janssen Stops Xarelto Cardiac Trial Due to Positive Data

Based on positive data, Janssen Research & Development says it has stopped early a Phase 3 trial (COMPASS) that was evaluating the efficacy and safety of Xarelto (rivaroxaban) for preventing major adverse cardiac events (MACE), including cardiovascular death, myocardial infarction and stroke in patients with coronary artery disease or with peripheral artery disease, is stopping earlier than planned. “This decision is based on the recommendation of the study’s independent data monitoring committee, as the primary MACE endpoint has reached its pre-specified criteria for superiority,” the company says.

The study enrolled 27,402 patients from more than 600 sites across more than 30 countries. Patients were randomized to receive either rivaroxaban 2.5 mg twice daily in addition to aspirin 100 mg once daily, rivaroxaban 5 mg twice daily alone, or aspirin 100 mg once daily alone. The company says it will present a complete data analysis at a medical meeting later this year, and it is completing a submission for FDA to add the indication on Xarelto’s approved label. The drug is currently approved for reducing the risk of stroke and blood clots in people with atrial fibrillation not caused by a heart valve problem.

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