Justify Sample Size Hike in FDC Trial of Zibotentan-Dapagliflozin, CDSCO Panel Tells AstraZeneca
New Delhi: Reviewing the amendment protocol of the AstraZeneca's fixed dose combination (FDC) Zibotentan plus Dapagliflozin, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) opined that the firm should submit more detailed justification for Increase the number of sample size from 1500 to1800 for further review.
This came after the firm presented protocol amendment version 2.0 dated 14 Feb 2025 protocol no. D4325C00010.
Zibotentan is an orally available selective antagonist of the endothelin-A (ET-A) receptor with potential antineoplastic activity. Zibotentan binds selectively to the ET-A receptor, thereby inhibiting endothelin-mediated mechanisms that promote tumor cell proliferation.
Dapagliflozin is in a class of medications called sodium-glucose co-transporter 2 (SGLT2) inhibitors. It lowers blood sugar by causing the kidneys to get rid of more glucose in the urine.
Dapagliflozin is used together with proper diet and exercise to treat type 2 diabetes. It works in the kidneys to prevent absorption of glucose (blood sugar). This helps lower the blood sugar level. Dapagliflozin does not help patients who have insulin-dependent or type 1 diabetes.
At the recent SEC meeting for Renal held on 20th May 2025, the expert panel reviewed the protocol amendment version 2.0 dated 14 Feb 2025 protocol no. D4325C00010.
After detailed deliberation, the committee opined that the firm shall submit more detailed justification for Increase the number of sample size from 1500 to1800 for further review by the committee.
Also Read: CDSCO Panel Clears Sanofi's Updated Myozyme Insert, Seeks Revision on Administration Guidance
