Drug developed by Indian American Salim Shah’s company Sarfez receives FDA approval

Salim Shah
Salim Shah

Soanz provides a new low-cost treatment option to people suffering from heart failure and chronic kidney disease.

A new drug developed by a pharmaceutical firm founded by Indian American Salim Shah has received approval from the US Food and Drug Administration.

Soaanz, developed by Sarfez Pharmaceuticals, 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 drug will hit the market in a couple of months, Shah told the American Bazaar on Monday.

Soaanz received the FDA approval on June 17. Sarfez, a Vienna, VA, -based company, applied for the FDA approval for the drug in 2019. It started the clinical trials last year.

A once-a-day extended release formulation of torsemide, Soaanz is said to 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, according to the company.

READ: Indian American Salim Shah’s Sarfez Pharmaceuticals to begin clinical trials for new heart failure drug early next year (September 27, 2019)

Unlike loop diuretics — the typical drug of choice when it comes to heart failure and chronic kidney disease treatment —  the newly approved drug offers effects without causing excessive urination.

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

Heart failure occurs when the heart cannot pump enough blood and oxygen to support other organs in the body. It affects nearly 1.8 percent of the US population, or about 5.7 million Americans, according to the Centers for Disease Control and Prevention. More than half a million new heart failure cases are diagnosed each year.

CDC says about half of people who develop heart failure die within five years of diagnosis and it costs an estimated $30.7 billion each year.

The newly approved drug will also be offered at a much lower cost, according to the founder, who aims to price it at one fifth the cost of competing brands.

When the company applied for the FDA approval, Shah had told the American Bazaar that Soaanz would be sold at a “reasonable price,” if it received the approval.

“The company has benefited from grants from the Small Business Administration and the National Institute of Health to develop Soaanz,” he said in a July 2019 interview. “We will transfer these benefits to patients by selling the drug at reasonable prices.”

On Monday, he reiterated that.

READ: Indian American Salim Shah’s Sarfez Pharmaceuticals to begin clinical trials for new heart failure drug early next year (September 27, 2019)

“My issue is that most heart patients are 65 and older, 70 percent of my patients are [like that]. They are on Medicaid or Medicare programs with limited disposable income so setting a price at $400 or $500 a month just doesn’t make any sense,” Shah said.

Instead Shah is aiming at a price closer to $30 or $40 a month, in an effort to reach the maximum number of people. “We’re going to price this drug based on our patients’ affordability, not how much we can get from insurance companies or what the market dictates.”

“We feel that lowering our costs to help improve care for these patients is our obligation as a healthcare company.”

In addition to Sarfez, Shah runs another specialty pharmaceutical company, Hingez Therapeutics, Inc. In 2018, the company received a grant of more than $1.8 million from the National Institutes of Health to develop a drug to treat high cholesterol.

READ: Hingez Therapeutics, founded by Indian American Salim Shah, gets $1.8 million NIH grant to develop drug (September 18, 2018)

Born in Bulandshahar, Uttar Pradesh, Shah grew up in Delhi. He earned a bachelor’s degree in zoology from Delhi University, a master’s in biotechnology from Aligarh Muslim University and a PhD in molecular genetics and biochemistry from the Jawaharlal Nehru University in New Delhi.

Shah also received a law degree (JD) from George Mason University in Virginia. He has also practiced regulatory and intellectual law in Washington, DC.

In the past, Shah served as the Managing Director of APJ laboratories, a pharmaceutical manufacturing firm with a portfolio of more than 50 products, including injectable and anti-invectives, and as the CEO of Osmotherapeutics, a natural products company.

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