Eli Lilly (NYSE:LLY) has received Fast Track designation from FDA to investigate tirzepatide in obese or overweight adults with weight-related comorbidities.
The Fast Track status is designed to compress the time needed for FDA to approve tirzepatide for use in adults with obesity or overweight with weight-related comorbidities.
The drug is a glucose-dependent insulinotropic polypeptide (GIP) and glucagon-like peptide-1 (GLP-1) receptor agonist (RA) that GlobalData believes has blockbuster potential.
In May, the FDA approved tirzepatide, marketed under the trade name Mounjaro, to treat adults with Type 2 diabetes.
Lilly’s competitor, Novo Nordisk (CPH:NOVO-B), has developed a similar drug, semaglutide, a glucagon-like peptide 1 receptor agonist. Semaglutide is also indicated for adults with Type 2 diabetes.
Last June, FDA approved Wegovy for Type 2 diabetes. Weekly semaglutide treatment for obesity first won approval in 2017.
The tirzepatide molecule is a 39 amino acid linear peptide conjugated to a C20 fatty acid moiety. Tirzepatide image from Lilly.
Lilly plans on beginning a rolling submission of a new drug application for tirzepatide in obese or overweight adults later this year. In addition, the company will supply data from the Phase 3 SURMOUNT-1 clinical trial and early data from SURMOUNT-2, scheduled for completion at the end of April 2023.
“We are pleased with the FDA’s decision to grant Fast Track designation for the drug, and we look forward to completing our rolling submission next year,” said Mike Mason, president of Lilly Diabetes, in a news statement.
According to government statistics, approximately one in three adults in the U.S. are overweight.
“While diet and exercise are important steps, most patients don’t achieve their desired treatment goals with only diet and exercise,” Mason said in a statement. “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. Tirzepatide also helped nearly two-thirds of participants on the highest dose reduce their body weight by at least 20 percent in SURMOUNT-1.”
Filed Under: Cardiovascular, Metabolic disease/endicrinology
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