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The Subject Expert Committee (SEC), which advises the national drug regulator on drugs and trials approval matters, has recommended grant of permission for import and marketing of Eli Lilly's weight loss drug Mounjaro in India.
The Committee recommended the approval subject to the condition that the company should conduct phase IV clinical trials and fulfill the requirement of quality norms.
The recommendation is on a proposal filed by the company to grant permission to import and market six doses of the drug - tirzepatide 2.5mg/0.5 ml, 5mg/0.5ml,7.5mg/0.5 ml, 10mg/0.5ml,12.5mg/0 .5ml, and 15mg/0.5 ml solution for injection in a single dose prefilled pen and in a single-dose vial (additional indication).
The proposal was filed along with justification including India specific clinical study reports from two global studies in which India is also one of the participating countries, before the committee.
The company also informed that the pre-filled pens formulation is approved in US, European Union, United Kingdom, United Arab Emirates, Hong Kong, Kuwait and Quarter and the tirzepatide single dose vials are approved in US, EU and Egypt for chronic weight management.
The company also submitted two separate applications for both the dosage forms - single dose prefilled pens and single dose vials - for proposed indication to the Indian drug regulator, in the recent months.
"After detailed deliberation, the committee recommended for grant of permission for import and marketing of tirzepatide 2.5mg/0.5ml, 5mg/0.5ml, 7.5mg/0.5ml, 10mg/0.5ml, 12.5mg/0.5ml and 15mg/0.5ml solution for injection in a single dose prefilled pen and in a single dose vial for chronic weight management subject to condition that firm should conduct phase-IV clinical trial. In addition to the above, the firm should fulfil the requirement of CMC data," said the SEC for endocrinology and metabolism in its meeting held on June 19.
The firm should submit phase-IV clinical trial protocol to the Central Drugs Standard Control Organisation (CDSCO) within three months from the date of approval of the drug for further review by the committee. The drug is sold under the brands Mounjaro and Zepbound, in various countries.
According to agency reports, Eli Lilly earlier this year said that it has plans to launch the drug in various countries and announced deals to expand manufacturing capacity.
The company, in May, 2022, announced that it received approval from the US Food and Drug Administration (FDA) for Mounjaro injection, the once-weekly GIP (glucose-dependent insulinotropic polypeptide) and GLP-1 (glucagon-like peptide-1) receptor agonist indicated as an adjunct to diet and exercise to improve glycemic control in adults with type-2 diabetes.
"Mounjaro represents a different class of medicines introduced for adults with type 2 diabetes. It works differently by directly activating GIP and GLP-1 pathways to help regulate blood sugar," the company says in its website.
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