Drugs

Glaxo NDA Accepted for Anemia Drug

FDA has accepted for review a GlaxoSmithKline NDA for daprodustat, an oral hypoxia-inducible factor prolyl hydroxylase inhibitor for treating patients with anemia related to chronic kidney disease. The agency has set a 2/1/2023 user fee review action target date.

The submission is based on data from the ASCEND Phase 3 clinical trial program, which included five pivotal trials assessing the drug’s safety and efficacy. “These trials demonstrated that daprodustat improved and/or maintained hemoglobin (Hb) within the target level (10-11.5 g/dL) without increased major adverse cardiovascular events (MACE) in the intention-to-treat (ITT) populations in each pivotal study, when compared to the standard of care, an erythropoietin stimulating agent (ESA), across both non-dialysis and dialysis patient settings,” the company says.

Glaxo says daprodustat works by inhibiting oxygen-sensing prolyl hydroxylase enzymes that stabilize hypoxia-inducible factors, which can lead to transcription of erythropoietin and other genes involved in the correction of anemia, “similar to the physiological effects that occur in the human body at high altitude.”

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