The FDA granted a priority review to Merck and Bayer’s vericiguat for treatment of high-risk patients with chronic heart failure.
The companies based their new drug application on positive findings from a phase 3 trial in 5,050 patients comparing vericiguat or placebo in combination with other heart failure therapies.
The trial focused on patients with worsening chronic heart failure at high risk of repeated hospitalizations and death. The results showed a 10 percent reduction in the rate of cardiovascular death and hospitalizations
The FDA is expected to make a decision on the drug by Jan. 20, 2021.