Akums Drugs and Pharmaceuticals Gets CDSCO Panel Nod To study Dapagliflozin plus Bisoprolol FDC
New Delhi: The Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organization (CDSCO) has granted permission to the drug major Akums Drugs and Pharmaceutical for conducting the phase III clinical trial for the fixed drug combination (FDC) of the Dapagliflozin Propanediol Monohydrate eq. to Dapagliflozin plus Bisoprolol Fumarate IP film coated tablet.
This came after Akums Drugs and Pharmaceutical presented the proposal before the committee along with the Phase III clinical trial protocol for two strengths i.e. Bisoprolol 5mg/10mg + Dapagliflozin 10mg/10mg tablets and requested for bioequivalence (BE) study waiver.
The propanediol form of dapagliflozin is a selective sodium-glucose co-transporter subtype 2 (SGLT2) inhibitor with antihyperglycemic activity. Upon administration, dapagliflozin selectively targets and inhibits SGLT2, thereby preventing the reabsorption of glucose by the kidneys.
Dapagliflozin is also indicated to either reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visit in adults with heart failure or reduce the risk of hospitalization for heart failure in adults with type 2 diabetes mellitus and either established cardiovascular disease or multiple cardiovascular risk factors.
Bisoprolol is a cardio selective β1-adrenergic blocking agent used to treat high blood pressure. It is considered a potent drug with a long-half life that can be used once daily to reduce the need for multiple doses of antihypertensive drugs
At the recent SEC meeting for cardiovascular held on 5th June 2024, the expert panel reviewed the proposal before the committee along with the Phase III clinical trial protocol for two strengths i.e. Bisoprolol 5mg/10mg plus Dapagliflozin 10mg/10mg tablets.
