Eris Lifesciences Gets CDSCO Panel Nod To Study FDC Dapagliflozin plus Bisoprolol Fumarate
New Delhi: Granting the waiver of the bioequivalence study, the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) has given its nod to Eris Life Sciences to conduct a Phase III clinical trial of the fixed-dose combination drug Dapagliflozin plus Bisoprolol.
This came after the firm presented the proposal before the committee along with the Phase III clinical trial protocol with a request for a bioequivalence (BE) study waiver.
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 mainly used to treat type 2 diabetes. It can also be used to treat heart failure and chronic kidney disease (CKD). Dapagliflozin is usually prescribed if: you have type 2 diabetes and cannot take metformin.
By inhibiting SGLT2, dapagliflozin blocks the reabsorption of filtered glucose in the kidney, increasing urinary glucose excretion and reducing blood glucose levels. Its mechanism of action is independent of pancreatic β cell function and modulation of insulin sensitivity.
Bisoprolol is a beta blocker medicine used to treat high blood pressure (hypertension) and heart failure. If you have high blood pressure, taking bisoprolol helps prevent future heart disease, heart attacks, and strokes. Bisoprolol is also used to prevent chest pain caused by angina.
Bisoprolol is a competitive, cardioselective β1-adrenergic antagonist. When β1-receptors (located mainly in the heart) are activated by adrenergic neurotransmitters such as epinephrine, both the blood pressure and heart rate increase, leading to greater cardiovascular work, and increasing the demand for oxygen. Bisoprolol reduces cardiac workload by decreasing contractility and the need for oxygen through competitive inhibition of β1-adrenergic receptors.
Bisoprolol is also thought to reduce the output of renin in the kidneys, which normally increases blood pressure. Additionally, some central nervous system effects of bisoprolol may include diminishing sympathetic nervous system output from the brain, and decreasing blood pressure and heart rate.
The therapeutic efficacy of Dapagliflozin can be increased when used in combination with Bisoprolol.
At the recent SEC meeting for Cardiovascular and Renal, the expert panel reviewed the proposal presented by Eris Life Sciences along with the Phase III clinical trial protocol with a request for a bioequivalence (BE) study waiver.
After detailed deliberation, the committee considered the request for waiver of BE study and recommended for grant of permission to conduct of Phase III clinical trial. The result of the Phase III clinical trial should be presented before the committee for further review.
