CDSCO Panel Approves Bayer's Real-World Use Study for Heart Failure Drug Vericiguat
New Delhi: The Subject Expert Committee (SEC) under the Central Drugs Standard Control Organisation (CDSCO) has granted approval to Bayer Pharmaceuticals Pvt. Ltd. to conduct a retrospective, non-interventional database study evaluating real-world drug use patterns of Vericiguat film-coated tablets (2.5 mg, 5 mg, and 10 mg).
The proposal, presented during the Cardiovascular SEC meeting held on April 9, 2025, aimed to assess real-world utilization of Vericiguat under Study No. 22613 (Version 1.0, dated September 6, 2024).
Vericiguat belongs to a class of drugs known as soluble guanylate cyclase (sGC) stimulators. It helps relax blood vessels, thereby improving blood flow. Clinically, Vericiguat is used to reduce the risk of cardiovascular death and hospitalization in certain adults with heart failure.
After detailed deliberation, the expert committee recommended approval for the proposed non-interventional study based on the protocol submitted by the firm.
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