Zuventus Healthcare gets CDSCO Panel Nod To Manufacture, Market Edoxaban film-coated tablets
New Delhi: Zuventus Healthcare has got the go-ahead from the Subject Expert Committee (SEC) functional under the Central Drug Standard Control Organisation (CDSCO) to manufacture and market a novel oral anticoagulant drug, Edoxaban 15, 30, and 60 mg film-coated tablets, with the condition of conducting a Phase IV clinical trial.
Edoxaban is a member of the Novel Oral Anti-Coagulants (NOACs) class of drugs and is a rapidly acting, oral, selective factor Xa inhibitor. By inhibiting factor Xa, a key protein in the coagulation cascade, edoxaban prevents the stepwise amplification of protein factors needed to form blood clots.
It is indicated to reduce the risk of stroke and systemic embolism (SE) in patients with nonvalvular atrial fibrillation (NVAF) and for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) following 5–10 days of initial therapy with a parenteral anticoagulant.
At the recent SEC meeting for Cardiovascular held on June 5, 2024, the expert panel reviewed the BE study report for grant of permission to manufacture and market Edoxaban 15, 30, and 60 mg film-coated tablets, along with a request for CT waiver.
The committee noted that Edoxaban has a lower risk of bleeding without comprising efficacy and more efficacy as compared to other NOACs.
Furthermore, the expert panel noted that there are no drug interactions with proton pump inhibitors (PPI), and the drug is approved in the US, Japan, and Canada.
