Exemed's Sitagliptin FDC Hits Roadblock as CDSCO Panel Flags No Added Safety Benefit
New Delhi: In a setback for Exemed Pharmaceutical, the Subject Expert Committee (SEC) under the Central Drugs Standard Control Organisation (CDSCO) has rejected the clinical trial conclusions of the company's proposed triple-drug fixed-dose combination (FDC), citing no foreseeable clinical advantage in terms of safety over dual-drug therapies.
The FDC under review comprises Sitagliptin Phosphate Monohydrate IP equivalent to Sitagliptin 100 mg/100 mg, Glimepiride IP 1 mg/2 mg, and Metformin Hydrochloride IP (as extended-release) 1000 mg/1000 mg tablets, submitted under file number FDC/MA/22/000360. The application was assessed during a recent SEC meeting, following earlier discussions held on 18 May 2023 and 19 May 2023.
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.
