FDA grants fast track designation to tirzepatide to treat obesity, overweight
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Today, Eli Lilly and Company received FDA fast track designation for tirzepatide to treat adults with obesity or overweight with weight-related comorbidities.
Tirzepatide (Mounjaro, Eli Lilly), a glucose-dependent insulinotropic polypeptide (GIP)/GLP-1 receptor agonist, was approved in May for treatment of adults with type 2 diabetes based on data from the SURPASS trial program. Those findings demonstrated that tirzepatide at 5 mg, 10 mg and 15 mg significantly reduced HbA1c for adults with type 2 diabetes and low rates of hypoglycemia.
FDA fast track designation is designed to provide expedited review for medications for serious conditions with unmet medical need. The review of tirzepatide will be based on results from the completed SURMOUNT-1 trial and the ongoing SURMOUNT-2 trial.
“We are pleased with the FDA's decision to grant Fast Track designation for tirzepatide, and we look forward to completing our rolling submission next year,” Mike Mason, president of Lilly Diabetes, said in the press release. “Obesity is a chronic disease that impacts the health of nearly 100 million Americans and is a significant driver of health care costs. While diet and exercise are important steps, most patients don't achieve their desired treatment goals with only diet and exercise.”
Findings from SURMOUNT-1 presented at the American Diabetes Association Scientific Sessions in June demonstrated that tirzepatide was associated with at least 5% weight loss over 72 weeks among adults with obesity and without diabetes. In addition, researchers observed at least 20% weight loss for more than half of participants receiving tirzepatide 15 mg.
“We are dedicated to helping people living with obesity through our research and development of innovative treatments like tirzepatide, which produced significant weight reductions in patients taking tirzepatide for type 2 diabetes in SURPASS,” Mason said. “Tirzepatide also helped nearly two-thirds of participants on the highest dose reduce their body weight by at least 20 percent in SURMOUNT-1.”
Lilly plans to initiate a rolling submission of a new drug application for tirzepatide for treating obesity and overweight later this year, according to the release.
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