sGC stimulator gets priority review by FDA for HFrEF treatment

The US Food and Drug Administration (FDA) has granted priority review to the New Drug Application (NDA) for the sGC stimulator vericiguat. This drug is under development for the treatment of patients with symptomatic chronic heart failure with an ejection fraction <45% following a worsening heart failure event.

This decision was based on data from the phase III VICTORIA study, presented at the ACC.20/WCC Virtual Congress and published in the NEJM. Vericuguat reduced the combined risk of first HHF or CV death.

Priority review designation means that the goal of the FDA is to take action on an application within 6 months of acceptance (instead of 10 months). Marketing authorization in the EU and Japan has been submitted.

Vericiguat is an investigational, oral, once-daily, stimulator of the soluble guanylate cyclase (sGC) enzyme. It restores the functioning of the NO-sGC-cGMP pathway. This pathway is insufficiently stimulated in HF patients, resulting in myocardial and vascular dysfunction.

Source: press release Bayer, July 16, 2020