Eli Lilly's Orforglipron Tablet gets CDSCO Panel Nod for Import, Marketing in India
New Delhi: Pharmaceutical major Eli Lilly and Company has received a positive recommendation from the Subject Expert Committee (SEC) under the Central Drugs Standard Control Organisation (CDSCO) for the import and marketing of Orforglipron tablets in multiple strengths after the expert panel reviewed data from a global Phase III clinical trial in which India was one of the participating countries.
The recommendation covers Orforglipron tablets in strengths of 0.8 mg, 2.5 mg, 5.5 mg, 9 mg, 14.5 mg, and 17.2 mg.
However, the expert panel stipulated that the drug should be sold at the retail level only on the prescription of an endocrinologist or an internal medicine specialist.
Further, the committee directed the company to conduct a Phase IV clinical trial following approval of the product. Accordingly, Eli Lilly and Company has been asked to submit the Phase IV clinical trial protocol within three months of receiving approval for review by the committee.
At the recent SEC meeting, the company presented its proposal seeking permission to import and market the drug Orforglipron tablets 0.8 mg, 2.5 mg, 5.5 mg, 9 mg, 14.5 mg, and 17.2 mg along with the Phase-III Global Clinical Trial Report in which India is one of the participating countries.
The committee noted that the applied drug has already received approval in the United States.
Orforglipron is an investigational oral, non-peptide glucagon-like peptide-1 (GLP-1) receptor agonist being developed for the management of metabolic disorders, including type 2 diabetes and obesity. Unlike currently available injectable GLP-1 receptor agonists, Orforglipron is designed as a once-daily oral therapy and does not require food or water restrictions for administration.
GLP-1 receptor agonists mimic the action of the naturally occurring GLP-1 hormone, which helps regulate blood glucose levels by stimulating insulin secretion, suppressing glucagon release, slowing gastric emptying, and promoting satiety. These mechanisms contribute to improved glycaemic control and weight reduction in patients with metabolic diseases.
After detailed deliberations, the committee recommended grant of permission for the import and marketing of Orforglipron Tablets 0.8 mg, 2.5 mg, 5.5 mg, 9 mg, 14.5 mg, and 17.2 mg, subject to the following conditions:
1. The drug should be sold by retail under prescription of endocrinologists or internal medicine specialists only.
2. The firm should conduct a Phase IV clinical trial for which the firm should submit the Phase IV clinical trial protocol within 3 months of approval of the drug for review by the committee.
