Dr.Reddy's Laboratories said entered into a partnership agreement with Bayerto market and distribute a second brand of Vericiguat in India.
Heart failure with reduced ejection fraction (HFrEF) is a major type of heart failure, and the China HF Study showed that 42% of heart failures in China are HFrEF, although several standard therapeutic classes of drugs are available for HFrEF and have reduced the risk of death and hospitalization for heart failure to some extent.
Merck and Bayer will jointly sponsor the trial that will enrol subjects from 34 countries.
KENILWORTH, N.J.--(BUSINESS WIRE)--Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced the initiation of VICTOR (VerICiguaT in adults with ChrOnic heart failure and Reduced ejection fraction), a pivotal Phase 3 randomized, placebo-controlled cardiovascular clinical trial of VERQUVO® (vericiguat) in patients with chronic heart failure and reduced ejection fraction of 40% or less who have not had a recent worsening heart failure event.
Bayer`s Verquvo (vericiguat) Receives Approval in Europe
The Food and Drug Administration (FDA) in the US has approved MSD’s (known as Merck in the US and Canada) heart failure treatment Verquvo (vericiguat).
Merck & Co. and Bayer on Tuesday won Food and Drug Administration approval for the heart failure drug Verquvo, one of the few medicines Merck has recently brought through late-stage development.
The drug will launch into a competitive field that includes Novartis' fast-growing Entresto and AstraZeneca's new entry Farxiga.
Bayer today announced the submission of the regulatory application seeking the approval of vericiguat in China. Vericiguat is an investigational oral, once-daily, first-in-class soluble guanylate cyclase (sGC)-stimulator being developed to treat patients with symptomatic chronic heart failure with an ejection fraction less than 45% who have had a previous worsening heart failure event (defined as heart failure hospitalization or receiving an intravenous diuretic for heart failure without hospitalization) in combination with available heart failure therapies. Vericiguat is being jointly developed with MSD (a tradename of Merck & Co., Inc., Kenilworth, NJ, USA).
The FDA has granted priority review status to Merck’s vericiguat, teeing the Big Pharma to receive an approval decision early next year. Vericiguat, which Merck partnered on with Bayer in a $1 billion deal, will enter the increasingly congested heart failure market if the FDA gives it the green light.