CDSCO Panel Tells Synokem to conduct phase 3 CT of antidiabetic FDC drug
New Delhi: Highlighting that there is no sufficient data, no unmet need & and FDC is not approved the drug internationally, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has opined the drug major Synokem Pharma to conduct a Phase III clinical trial (CT) of the antidiabetic fixed-dose combination drug Teneligliptin hydrobromide hydrate plus Metformin hydrochloride (SR) IP plus Dapagliflozinpropanediol monohydrate.
In respect of bioequivalence study waiver, the expert panel approves the request of the drug major Synokem Pharma. This came after the firm presented its proposal along with justification for bioequivalence study (BE) and clinical trial (CT) Study waiver.
Teneligliptin belongs to the class of anti-diabetic drugs known as dipeptidyl peptidase-4 inhibitors or gliptins. It is indicated for the management of type 2 diabetes mellitus (T2DM) in adults along with diet and exercise. Teneligliptin is currently used in cases showing insufficient improvement in glycemic control even after diet control and exercise or a combination of diet control, exercise, and sulfonylurea- or thiazolidine-class drugs.
At the recent SEC meeting for Endocrinology & Metabolism held on 19th and 20th January 2023, the expert panel reviewed the proposal presented by Synokem Pharmaceuticals along with justification for BE and CT Study waiver of the FDC drug Teneligliptin hydrobromide hydrate plus Metformin hydrochloride (SR) IP plus Dapagliflozinpropanediol monohydrate.
After detailed deliberation, the committee considered the request of the firm for BE study waiver.
However, with regard to the Phase III CT Study waiver, the committee noted that:
The FDC is not approved internationally.
Insufficient data presented by the firm.
There is no unmet need.
In view of the above observation, the committee reiterated its recommendation dated 18.03.2021 & 19.03.2021 with respect to Phase III CT Study. Accordingly, the expert panel directed that the firm should conduct the Phase III CT Study after taking NOC from CDSCO.
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