The FDA has granted priority review status to Merck’s vericiguat, teeing the Big Pharma to receive an approval decision early next year. Vericiguat, which Merck partnered on with Bayer in a $1 billion deal, will enter the increasingly congested heart failure market if the FDA gives it the green light.
Merck and Bayer have taken vericiguat to this point on the back of mixed data. Vericiguat failed a midphase trial and statistically was no better than placebo at reducing deaths in phase 3. However, the phase 3 did link the drug to a statistically significant reduction in a composite measure of cardiovascular deaths and heart failure hospitalization, causing it to hit its primary endpoint.