Merck and Bayer Receive the US FDA’s Priority Review for Vericiguat to Reduce the Risk of CV Death in Patients with Symptomatic Chronic Heart Failure with HFrEF

July 16, 2020 Auto Bot Bayer, FDA, Latest, Merck, patients, Priority Review, Receive, regulatory, risk 0

Shots:

  • The NDA is based on P-III VICTORIA study assessing vericiguat (qd, (titrated up to 10mg) vs PBO when given in combination with available HF therapies in ~5,050 patients with worsening CHF, reduced left VEF of <45% within 12mos. prior to randomization following a decompensation event
  • The 1EPs is the composite of time to the first occurrence of HF hospitalization or CV death. 2EPs included time to occurrence of CV death, time to the first occurrence of HF hospitalization, time to total HF hospitalizations (including first and recurrent events), time to the composite of all-cause mortality and time to all-cause mortality
  • Vericiguat is an orally administered soluble guanylate cyclase (sGC) stimulator with its anticipated PDUFA date as Jan 20, 2021

Click here to read full press release/ article | Ref: Businesswire | Image: USA Today