Drugs

Lexicon Re-files NDA for Heart Failure Drug

FDA has accepted for review a Lexicon Pharmaceuticals NDA resubmission for sotagliflozin, an investigational dual SGLT1 and SGLT2 inhibitor for treating heart failure. The agency set a 5/2023 user fee review action date. The company says the submission seeks the following indications:

To reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in adults with heart failure, including those with acute or worsening heart failure.
To reduce the risk of cardiovascular death, hospitalization for heart failure, urgent heart failure visit, nonfatal myocardial infarction, and nonfatal stroke in adults with Type 2 diabetes mellitus, chronic kidney disease, and other cardiovascular risk factors, including a history of heart failure.

The drug has had a troubled past. In 2019, CDER issued a complete response letter to Sanofi/Lexicon stating that the NDA could not be approved because its clinical data demonstrated that the addition of sotagliflozin to insulin was associated with an increased risk of diabetic ketoacidosis (DKA), a serious and often life-threatening consequence of insulin insufficiency. Two subsequent dispute resolution requests were rejected by CDER based on the determination that the drug’s DKA risk outweighed its benefits.

Lexicon says that a new analysis evaluating the clinical benefit of sotagliflozin in heart failure and blood glucose control across the full range of kidney function was presented at the American Heart Association Scientific Sessions in 2020. “Sotagliflozin significantly reduced total cardiovascular deaths, hospitalizations for heart failure, and urgent visits for heart failure, as well as decreased hemoglobin A1c, across the full range of kidney function studied, including individuals with moderate-to-severe chronic kidney disease,” it says.

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