Drugs

Praluent sBLA Accepted for Reduced MACE Labeling

FDA has accepted for review a Sanofi and Regeneron Pharmaceuticals supplemental BLA for Praluent (alirocumab) to update the Prescribing Information to include its effect in reducing the overall risk of major adverse cardiovascular events (MACE). MACE is a catch-all term that includes heart attack, ischemic stroke, death from coronary heart disease and unstable angina requiring hospitalization. The agency set a user fee rescription review action target of 4/28/2019.

The sBLA is based on data from the ODYSSEY OUTCOMES Phase 3 cardiovascular outcomes trial that assessed the effect of Praluent in 18,924 patients who had an acute coronary syndrome, such as a heart attack, between 1-12 months (median 2.6 months) before enrolling in the trial. Additionally, FDA recently approved an update to Praluent’s Prescribing Information to include clinical information regarding its use in patients with heterozygous familial hypercholesterolemia who require additional lowering of low-density lipoprotein cholesterol along with diet and maximally-tolerated statin therapy and who are undergoing apheresis treatment. Apheresis is a procedure where LDL-C is removed from the blood, in a process similar to kidney dialysis.

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