Present Rationality for combining FDC: CDSCO panel Tells Akum Pharma on Lobeglitazone, Sitagliptin FDC

In addition to this, the expert panel opined the firm to present justification on dose titration and International approval status.

This came after the firm presented its proposal along with justification for bioequivalance (BE) and Phase III clinical trial waiver.

Lobeglitazone is an antidiabetic medication from the thiazolidinedione class of drugs. It primarily functions as an insulin sensitizer by binding and activating Peroxisome Proliferator-Activated Receptors (PPAR) gamma within fat cells.

Lobeglitazone acts as an insulin sensitizer by binding and activating Peroxisome Proliferator-Activated Receptors (PPAR) gamma within fat cells.

Thiazolidinediones (TZDs) upregulate PPAR-gamma receptors in the central nervous system, leading to increased feeding. TZD agents expand adipose tissue mass via the maturation of preadipocytes into mature adipocytes and increase fat storage by increasing free fatty acid movement into cells.

Sitagliptin phosphate monohydrate is an oral antihyperglycemic (antidiabetic drug) of the dipeptidyl peptidase-4 (DPP-4) inhibitor class. Sitagliptin phosphate works to competitively inhibit the enzyme dipeptidyl peptidase 4 (DPP-4).

Sitagliptin increases insulin production and decreases hepatic glucose overproduction. Sitagliptin prolongs the action of GLP-1 and GIP. By enhancing active incretin levels, sitagliptin increases insulin production and lowers glucagon secretion from alpha cells, which decreases hepatic glucose overproduction.

Sitagliptin is used along with diet and exercise and sometimes with other medications to lower blood sugar levels in adults with type 2 diabetes (a condition in which blood sugar is too high because the body does not produce or use insulin normally).

At the recent SEC meeting for Endocrinology and Metabolism held on 15th and 16th June 2023, the expert panel reviewed the proposal along with justification for BE & Phase III clinical trial waiver for the FDC Lobeglitazone sulfate plus Sitagliptin Phosphate monohydrate tablets.

After detailed deliberation, the committee recommended that the firm should present the followings:

1. Justification and rationality for combining this FDC and its significant benefit.

2. Justification on dose titration.

3. International approval status.

4. Scientific literature available from peer-reviewed journals in support of combining the two drugs in this FDC.

Accordingly, the expert panel stated that the firm should submit a justification to CDSCO for review by SEC.

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