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

  Ref: Businesswire | Image: Merck