Bayer AG BAYRY announced it has submitted a regulatory application in China seeking approval for its investigational drug, vericiguat, to treat patients with symptomatic chronic heart failure with an ejection fraction (HFrEF) less than 45%, who have had a previous worsening heart failure event, in combination with available heart failure therapies. Vericiguat is being jointly developed with Merck and Co. MRK.
Vericiguat is an investigational, oral, once-daily, direct stimulator of the soluble guanylate cyclase (sGC) enzyme.
Shares of the company have lost 19.1% so far this year against the industry’s 1.4% growth.
The new drug application (NDA) was submitted to the Center of Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA), which was based on positive Phase III data from the VICTORIA study. The VICTORIA study evaluated vericiguat versus placebo when given in combination with available heart failure therapies in patients with worsening chronic HFrEF.
In July, the FDA accepted for priority review the NDA for vericiguat. The FDA set an action date of Jan 20, 2021. The marketing authorization application (MAA) submitted to the European Medicines Agency (EMA) and the NDA to the Ministry of Health, Labor and Welfare (MHLW) in Japan were based on positive phase III data from the VICTORIA study.
About 13.7 million patients are living with heart failure in China. Despite huge progress made on addressing this disease, the cardiovascular event rates are high, creating a huge unmet need for new therapies to reduce the risk of death and hospitalizations.
Novartis’ NVS Entresto is approved to treat HFrEF. Amgen AMGN and partner Cytokinetics’s pipeline candidate,omecamtiv mecarbil, is in late-stage development for HFrEF. AstraZeneca’s SGLT2 inhibitor,Farxiga, is also being evaluated in two phase III studies for HFrEF and heart failure with preserved ejection fraction (HFpEF).
Bayer currently carries a Zacks Rank #4 (Sell).
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