Drugs

Pfizer Taps Oral Danuglipron Formulation for Obesity

Pfizer says it has selected its preferred once-daily modified-release formulation for danuglipron, an oral glucagon-like peptide-1 (GLP-1) receptor agonist it is developing for treating obesity. The company plans to conduct dose optimization studies later this year that will assess multiple doses of the selected modified-release formulation to “inform the registration enabling studies.” Current in-demand FDA-approved GLP-1 receptor agonist weight loss drugs Wegovy (Novo Nordisk’s semaglutide) and Zepbound (Eli Lilly’s tirzepatide) are injectables.

“Obesity is a key therapeutic area for Pfizer, and the company has a robust pipeline of three clinical and several pre-clinical candidates,” the company says in a release. “The most advanced of them, danuglipron, has demonstrated good efficacy in a twice-daily formulation, and we believe a once-daily formulation has the potential to have a competitive profile in the oral GLP-1 space.”

An ongoing open-label, randomized study is evaluating danuglipron’s pharmacokinetics and safety in healthy adults 18 years or older, Pfizer says. “To date, study results have demonstrated a pharmacokinetic profile supportive of once-daily dosing. with a safety profile consistent with prior danuglipron studies including no liver enzyme elevations observed in more than 1,400 study participants.”

Pfizer says danuglipron was discovered and developed in-house at Pfizer, and it is designed to keep blood sugar at healthy levels and works by increasing the amount of insulin released. “Other potential effects include slowing down the digestion of food and increasing the feeling of fullness after eating, which may be associated with weight loss,” 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