INDIA – Bayer is rolling-out its new therapy vericiguat, Verquvo, which helps reduce hospitalization and mortality in patients with worsening heart failure.

The once-a-day drug is being launched in line with the rest of the world, and is priced at an India-specific price of ₹127 (US$1.6) per pill, which is about 1/15 th the global price, according to Business Line.

Chronic heart failure is a substantial economic and public health burden in India and is estimated to be affecting 10 million people with heart failure, occurring in patients that are a decade younger than their Western counterparts.

Despite the substantially younger age of patients, three out of five Indian patients will die within five years of diagnosis, company officials said.

Vericiguat is a soluble guanylate cyclase (sGC) stimulator, indicated with standard care in adults with symptomatic chronic heart failure.

The drug works on a pathway not currently targeted by existing heart failure treatments and can reduce the risk of cardiovascular death and heart failure hospitalization, added Dr. Ashish Gawde, Country Medical Director.

Chronic heart failure occurs when the heart is not able to pump blood as well as it should. Thickening of arteries (atherosclerosis), heart attack, infections, or rheumatic heart disease make the heart muscle weak or stiff, so it cannot pump blood effectively.

The heart failure segment is estimated to be about ₹20,000 crore (US$2.4 billion) while worsening heart failure is about ₹1200 crore (US$146.7 million).

Commercial rights

Interestingly, Bayer and Merck have a worldwide collaboration in the field of sGC modulators. The vericiguat program is being co-developed by Bayer and Merck.

Merck has the commercial rights to vericiguat in the US and Bayer has exclusive commercial rights in the rest of world.

Bayer received approval of vericiguat in India based on the results of its Phase III VICTORIA trial, published in The New England Journal of Medicine (NEJM) in March 2020.

The drug is not given to pregnant women. Vericiguat was approved for use by the US FDA in January 2021, and by the European Commission in July 2021.

Vericiguat is approved for use by the US Food and Drug Administration (FDA) in January 2021, and by the European Commission in July 2021, the statement said.

In other related news, the European Commission (EC) has granted marketing authorization for Jardiance as a treatment for adults with symptomatic chronic heart failure, Boehringer Ingelheim and Eli Lilly have announced.

Jardiance now becomes the only approved treatment in Europe for adults with symptomatic chronic heart failure regardless of ejection fraction.

The landmark approval makes Jardiance the first and only approved treatment for all adults with symptomatic chronic heart failure, which includes patients across the full spectrum of Left ventricular ejection fraction (LVEF), including both heart failure with reduced and preserved ejection fraction.

Heart failure affects more than 15 million people in Europe and causes almost 2 million hospital admissions yearly.

Approximately half of these patients have HFpEF, which has been described as the single largest unmet need in cardiovascular medicine based on prevalence, poor outcomes, and the absence of treatment options until now.

Consequently, with Jardiance’s entry into the EU market, AstraZeneca’s Farxiga is likely to suffer serious competition to its market share in the heart failure space as an increasing number of adults are diagnosed with the condition.

It is likely that Jardiance will capture an increased market share in the EU for the treatment of HF, with or without T2D, with this share increasing once Lilly and Boehringer Ingelheim are also able to determine its efficacy for treating Chronic kidney disease (CKD), according to GlobalData.

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