Bayer submitted vericiguat for market authorization in China
Bayer has announced that it has submitted an application requesting the approval of vericiguat in China for the treatment of chronic heart failure.
The application was submitted based on the VICTORIA study. VICTORIA is a Phase 3, randomized, double-blind, placebo-controlled study. Five thousand fifty patients with chronic heart failure were enrolled in the study, composite of death from cardiovascular disease, or hospitalization was considered as the primary endpoint. Over a median of 10.8 months, the primary outcome event has occurred in 35.5% of patients who were on the vericiguat group compared to 38.5% in the placebo group.
Vericiguat is the first guanylate cyclase (sGC)-stimulator indicated for treating patients with symptomatic heart failure. The drug is administered once a day orally. The drug is developed by Bayer in collaboration with MSD. Vericiguat acts by restoring the NO-sGC-cGMP pathway. sGC is less stimulated in patients with heart failure, thereby causing myocardial and vascular dysfunction.
Market authorization applications have been to the regulatory agencies of Europe and Japan. The product has received priority review in the United States.
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