FDA grants fast review for Bayer and MSD’s heart failure drug vericiguat

pharmafile | July 17, 2020 | News story | Medical Communications Bayer, FDA, MSD 

The FDA has granted a fast Priority Review for Bayer and MSD’s heart failure drug vericiguat.

This was based on data from the Phase 3 VICTORIA study, which met its composite primary endpoint as the drug reduced the risk of heart failure hospitalisation or cardiovascular death in patients with worsening chronic heart failure with reduced ejection fraction when compared with a placebo control group.

There was also 7% fewer deaths in the drug group, but this were not statistically significant. The secondary endpoints included time to occurrence of cardiovascular death, time to first occurrence of heart failure hospitalisation and time to all-cause mortality.

In 2016, MSD paid $1 billion for the US rights to the drug, and the FDA’s Priority Review means a decision on its approval should be decided by 20 January 2021.

Dr. Roy Baynes, Senior Vice President, Head of Global Clinical Development and Chief Medical Officer at MSD, said: “This submission builds on Merck’s commitment to patients with cardiovascular disease and long legacy of advancing cardiovascular research to meet unmet medical needs. We look forward to working with the FDA as they review this New Drug Application for vericiguat.”

Conor Kavanagh

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