Alkem gets CDSCO panel okay to manufacture, market Metformin, Sitagliptin FDC

Sitagliptin is an oral dipeptidyl peptidase-4 (DPP-4) inhibitor used for the management of type 2 diabetes mellitus. Sitagliptin inhibits DPP-4, which leads to increased levels of glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP), decreased levels of glucagon, and a stronger insulin response to glucose.

Earlier, at the 87th SEC meeting for Endocrinology & Metabolism held on June 15, 2021 and June 16, 2021 at CDSCO, the drug-maker Alkem  presented the BE protocol before the committee and requested manufacturing and marketing approval based on the BE study.

In response, the committee then noted that the proposal was already approved in combi-kit form and that FDC was also approved in various other strengths.

Therefore, at the earlier meeting the firm was granted permission to conduct a BE study, and in addition to this, the firm was directed that the results of the study should be presented before the committee for further consideration.

At the latest SEC meeting, the committee thoroughly examined the proposal of Alkem and the BE study results of the said combination antidiabetic drug. After detailed deliberation, the committee recommended the manufacturing and marketing of the proposed FDC.