Mylan Pharmaceutical Gets CDSCO Panel Nod To study Selatogrel
New Delhi: Mylan Pharmaceutical has got approval from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to conduct the phase 3 clinical study of Selatogrel 16mg/0.5mL aqueous solution.
This came after the firm presented phase 3 clinical study protocol no.: ID-076A301 version: 5.0dated 09 June 2023. This is a multi-center, double-blind, randomized, placebo-controlled, parallel-group study to evaluate the efficacy and safety of self-administered subcutaneous selatogrel for prevention of all-cause death and treatment of acute myocardial infarction in subjects with a recent history of acute myocardial infarction.
Selatogrel, a 2-phenylpyrimidine-4-carboxamide analog, is a potent, reversible, and selective P2Y12 inhibitor administered subcutaneously that is under development for the treatment of acute myocardial infarction (AMI) in patients with a recent history of AMI.
Selatogrel is a drug that prevents platelets from aggregating by blocking the P2Y12 receptor on platelet surfaces. This reduces the risk of blood clots and is used to treat acute myocardial infarction (AMI).
At the recent SEC meeting for Cardiovascular, the expert panel reviewed the phase 3 clinical study protocol no.: ID-076A301 version: 5.0 dated 09 June 2023.
After detailed deliberation, the committee recommended the grant of permission to conduct the trial as presented by the firm.
