Drugs

Lexicon Submits New Data to FDA on Zynquista

Lexicon Pharmaceuticals says FDA is requiring additional time to review its new clinical data submitted earlier this month in an effort to advance its stalled NDA for its diabetes drug Zynquist (sotagliflozin). The company is seeking to address concerns raised in a 12/2024 complete response letter that cited an elevated risk of diabetic ketoacidosis (DKA) with the oral SGLT1/SGLT2 inhibitor when used as an adjunct to insulin in adults with Type 1 diabetes.

The additional data came from three ongoing investigator-initiated studies: the STENO1 trial at the Steno Diabetes Center, the SUGARNSALT trial at the Joslin Diabetes Center, and the SOPHIST study at the University of Dundee, the company says. FDA had granted the company a Type D meeting to discuss potential regulatory paths forward, and feedback, which was expected by the end of the month, is now expected in the fourth quarter, it adds.

Despite gaining European approval in 2019, sotagliflozin’s regulatory path in the U.S. has been challenging. Late last year, FDA’s Endocrinologic and Metabolic Drugs Advisory Committee voted 11 to 3 against recommending approval due to DKA concerns. A previous submission was denied in a 2019 complete response letter, which cited deficiencies such as data demonstrating that the addition of sotagliflozin to insulin is associated with an increased risk of DKA.

Two Lexicon dispute resolution requests have been rejected by CDER based on a determination that the drug’s DKA risk outweighed its benefits.

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