Indian American firm’s heart drug gets FDAs approval

iNDICA NEWS BUREAU-

Sarfez Pharmaceuticals, a Virginia-based company founded by an Indian American scientist Salim Shah, has developed a new drug to treat people suffering from heart failure.

This drug, SoanzXR was in the waiting line to get approval from the US Food and Drug Administration since 2019, and now the FDA has given the green signal for the company.

The drug provides a new treatment option to people suffering from heart failure who experience constant edema, swelling in the lower limbs and abdomen, despite a loop diuretic therapy, as well as patients with chronic kidney disease”, the American Bazaar media outlet reported.

According to the company, the drug called SoanzXR “provides a new treatment option to people suffering from heart failure who experience persistent edema, swelling in the lower limbs and abdomen, despite a loop diuretic therapy, as well as patients with chronic kidney disease”, the American Bazaar media outlet reported.

It is the first and only long-acting loop diuretic in the form of water pill to deliver drug at a slower pace for most of the day to treat volume overload caused by heart failure and chronic kidney disease said the company. SoanzXR also offers improved treatment options for people with chronic kidney disease, liver cirrhosis with ascites, and hypertension, said the pharma developing company.

He added that the drug received the FDA approval on June 17 after the company had applied for the green light in 2019. Clinical trials had commenced last year.

“SoanzXR is specifically formulated to reduce excessive urination in heart failure patients,” Shah, a resident of Vienna, Virginia, told reports.

“We believe that for many of these patients who are aged 65 and older, the new treatment option now approved by the FDA offers tremendous benefits.”

According to the US Centers for Disease Control and Prevention, heart failure affects nearly 1.8 per cent of the country’s population, or about 5.7 million Americans.

Explaining it further, Shah, said: “SoanzXR will be the first long-release drug to treat heart failure, chronic kidney disease, and uncontrolled hypertension patients, greatly improving quality of life and hopefully reducing hospitalization time for chronic congestive heart failure patients.”

SoanzXR is unique due to its longer duration compared to currently available loop diuretics in the market which have a very short duration of action, and as a result, most patient remain volume overloaded requiring repeat hospitalization. Moreover, the oral extended-release tablet induces gradual and sustained urination, reducing the need for frequent urination, noted the company.

Shah, who received his Ph.D. in biochemistry from JNU, New Delhi, formed Hingez Pharma in the US and is now specializing in developing drugs.