Exemed's Sitagliptin FDC Hits Roadblock as CDSCO Panel Flags No Added Safety Benefit

Responding to those earlier recommendations, the company submitted an updated dossier that included both its bioequivalence (BE) study and Phase III clinical trial report.

While the committee accepted the BE study, it expressed dissatisfaction with the clinical trial data. The panel observed that there was no significant difference in efficacy and safety parameters between the trial groups (T1 and T2). Moreover, although statistical significance in efficacy was recorded when compared to a two-drug combination, the committee emphasized that this did not reflect any clinical advantage in safety.

The expert panel noted;

“There is no foreseeable clinical advantage w.r.t safety of three drugs combination over two drug combination even though there is statistical significance in efficacy as compared to two drugs combination, which is expected.”

Accordingly, the clinical trial results and conclusions were not approved by the committee.