FDA, which has accepted the New Drug Application for SoanzXR, is expected to complete review by mid-January.
Sarfez Pharmaceuticals, a company founded by Indian American Salim Shah, has developed a new drug that would provide a new treatment option to people suffering from heart failure.
SoanzXR, a once-a-day extended release formulation of torsemide, will effectively reduce volume overload and blood pressure, according to the company. Torasemide is used to treat high blood pressure and fluid overload because of heart failure, kidney disease and liver disease.
The New Drug Application for SoanzXR has been accepted by the US Food and Drug Administration, Sarfez said in a press release. The FDA is expected to complete the review by January 14, 2020.
If approved, it will be the first and only long acting loop diuretic (water pill) that delivers the drug at a slower rate and provides drug effects for the majority of the day with a single dose. Diuretics are substances that help to increase production of urine. Loop diuretics are used to treat volume overload caused by heart failure and chronic kidney disease.
“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,” said Shah, Founder and Chairman of Sarfez. “We look forward to supporting the FDA throughout SoanzXR’s review process and once approved, providing improved treatment options for our patients.”
The company said SoanzXR also offers improved treatment options for people with chronic kidney disease, liver cirrhosis with ascites, and hypertension.
What is unique about SoanzXR is its longer duration. Currently all the loop diuretics available in the market have a very short duration of action, and as a result, most patient remain volume overloaded despite taking in these drugs at optimal doses.
It is important because most chronic heart failure patients that get hospitalized, or frequently re-admitted, are volume overloaded.
The Centers for Disease Control and Prevention estimates show that hospitalization due to chronic heart failure is costing more than $10 billion to the healthcare system, the company pointed out. Additionally, immediate release loop diuretics are high-ceiling diuretics that cause strong and sudden urge for urination, which may result in urninary incontinence especially in older women.
According to Sarfez, SoanzXR, an oral extended-release tablet, has significantly longer duration of action compared to other marketed immediate release loop diuretics. The drug induces gradual and sustained urination, improving the quality of life for patients, and its effect lasts most of the day, the company said.
Shah said, if the drug is approved, his company will provide SoanzXR at a reasonable price.
“The company has benefited from grants from the Small Business Administration and the National Institute of Health to develop SoanzXR,” he said. “We will transfer these benefits to patients by selling the drug at reasonable prices.”
Besides Sarfez, Shah has also founded Hingez Therapeutics, Inc, a specialty pharmaceutical company.
Last year, Hingez received a grant of more than $1.8 million from the National Institutes of Health to develop a drug to treat high cholesterol. That drug could potentially reach human trials within a year or two.
Shah, who was born in Bulandshahar, Uttar Pradesh, and grew up in Delhi, has served as the Managing Director of APJ laboratories, a pharmaceutical manufacturing company with a portfolio of more than 50 products, including injectable and anti-invectives, and as the CEO of Osmotherapeutics, a natural products company.
Shah received his PhD in molecular genetics and biochemistry from the Jawaharlal Nehru University in New Delhi. He has a master’s in biotechnology from Aligarh Muslim University, and bachelor’s in zoology from Delhi University. He received his law degree (JD) from George Mason University in Virginia. He has also practiced regulatory and intellectual law in Washington, DC.