Eli Lilly gets USFDA Fast Track designation for Tirzepatide to treat adults with obesity
Tirzepatide is a once-weekly GIP (glucose-dependent insulinotropic polypeptide) receptor and GLP-1 (glucagon-like peptide-1) receptor agonist.;
Indianapolis: Eli Lilly and Company has announced that the U.S. Food and Drug Administration (USFDA) has granted Fast Track designation for the investigation of tirzepatide for the treatment of adults with obesity, or overweight with weight-related comorbidities.
The USFDA grants Fast Track designation to facilitate the development and expedite the review of medicines to treat serious conditions and fill an unmet medical need. Fast Track designation is intended to bring promising medicines to patients sooner.
Tirzepatide is a once-weekly GIP (glucose-dependent insulinotropic polypeptide) receptor and GLP-1 (glucagon-like peptide-1) receptor agonist. Tirzepatide is a single novel molecule that activates the body's receptors for GIP and GLP-1, which are natural incretin hormones.
Based on discussions with the USFDA, Lilly plans to initiate a rolling submission of a new drug application (NDA) for tirzepatide in adults with obesity or overweight this year, which when complete, will be based primarily on results from two Phase 3 clinical trials: SURMOUNT-1, which is complete, and SURMOUNT-2, which is expected to complete by the end of April 2023. The rolling submission allows Lilly to submit completed sections of an application for review by FDA, rather than wait until all sections are completed.
Read also: Justify protocol amendments in detail: CDSCO Panel tells Eli Lilly on Trail of Imlunestrant
Disclaimer: This website is primarily for healthcare professionals. The content here does not replace medical advice and should not be used as medical, diagnostic, endorsement, treatment, or prescription advice. Medical science evolves rapidly, and we strive to keep our information current. If you find any discrepancies, please contact us at corrections@medicaldialogues.in. Read our Correction Policy here. Nothing here should be used as a substitute for medical advice, diagnosis, or treatment. We do not endorse any healthcare advice that contradicts a physician's guidance. Use of this site is subject to our Terms of Use, Privacy Policy, and Advertisement Policy. For more details, read our Full Disclaimer here.
NOTE: Join us in combating medical misinformation. If you encounter a questionable health, medical, or medical education claim, email us at factcheck@medicaldialogues.in for evaluation.