Drugs

Priority Review for AstraZeneca’s Farxiga for Kidney Disease

FDA has granted priority review for AstraZeneca’s Farxiga (dapagliflozin) for treating new or worsening chronic kidney disease (CKD) in adults with and without Type 2 diabetes. The designation was based on clinical evidence from the DAPA-CKD Phase 3 trial showing Farxiga, on top of standard of care consisting of an ACE inhibitor or an angiotensin receptor blocker, reduced the risk of the composite of worsening of renal function or risk of cardiovascular or renal death by the 39%, compared to placebo in patients with CKD stages 2-4 and elevated urinary albumin excretion. It also significantly reduced the risk of death from any cause by 31%.

AZ says the safety and tolerability of Farxiga were consistent with the medicine’s safety profile.

Last March an independent data monitoring committee recommended the trial be stopped early, based on a determination of overwhelming efficacy.

Farxiga received FDA breakthrough therapy designation for patients with CKD with and without Type 2 diabetes. It is indicated in the U.S. as an adjunct to diet and exercise to improve glycemic control in adults with Type 2 diabetes and to reduce the risk of hospitalization for heart failure in patients with Type 2 diabetes and established cardiovascular disease or multiple cardiovascular risk factors. In 3/2020 it was approved in the U.S. to reduce the risk of cardiovascular death and hospitalization for heart failure in adults with heart failure with reduced ejection fraction with and without Type 2 diabetes. Farxiga is not indicated to reduce the worsening of renal function or death in patients with CKD.

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