CDSCO panel asks Hetero to resubmit Bioequivalence protocol for Trelagliptin Succinate tablet
New Delhi: Noting that the protocol was not scientifically designed and the safety of the study subjects was not taken care of, the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organization (CDSCO) has directed Hetero to submit a well-designed Bioequivalence (BE) protocol for Trelagliptin Succinate tablet to CDSCO for further review by the panel.
This came after the drugmaker presented the proposal for Trelagliptin Succinate 50/100 mg tablet along with the BE protocol before the committee. BE or Bioequivalence of a drug product is achieved if its extent and rate of absorption are not statistically significantly different from those of the reference product when administered at the same molar dose.
The said formulation, Trelaliptin Succinate is a potent, orally active, and highly selective DPP-4 inhibitor. It helps in controlling the blood glucose levels. It works by inhibiting DPP-4 selectively and continually. DPP-4 is an enzyme responsible for inactivating the glucagon-like peptide-1 and glucagon-dependent insulinotropic polypeptide. This way, it helps in regulating blood glucose.
The CDSCO Committee, during its 72nd meeting held on 16.12.2020, thoroughly examined all the proposals related to Endocrinology and Metabolism and made some recommendations as well. They minutely scrutinized the proposal regarding the Trelapliptin Succinate tablets made by Hetero.
While reviewing the proposal made by the firm, the committee observed that the proposal lacked proper scientific design. It opined that the firm should make a resubmission regarding the matter with a well-designed protocol. It noted;
"The committee noted that the protocol was not scientifically designed and the safety of the study subjects was not taken care of and therefore protocol presented by the firm was not acceptable in the present form."
After detailed deliberation, the committee recommended that the firm should submit a well-designed protocol to CDSCO for further review by the committee.
Hetero has a presence in over 126 countries and is engaged in the development, manufacturing, and marketing of high-quality Chemical and Biologic Drugs across diverse therapeutic areas with 36 manufacturing facilities located worldwide.