FDA grants orphan drug designation to BIV201 for most ascites treatments

The FDA granted BioVie Inc. orphan drug designation for BIV201 for the treatment of ascites in all instances except those caused by cancer, according to the company.

“Orphan drug designation represents a major milestone supporting the clinical development and eventual commercialization of BIV201 therapy,” Jonathan Adams, CEO at BioVie, said in a press release. “It recognizes the importance of pioneering a new therapeutic approach for this relatively small group of desperately ill patients.”

According to the company’s website, its researchers hope BIV201’s main ingredient — a vasoconstrictor that has been shown to lower portal hypertension worldwide — cuts off the route in which ascites develops, halting accelerating fluid generation. This main ingredient, not yet available in the United States, has been approved outside the U.S. to treat two conditions that share comparable beginnings: esophageal variceal bleeds and type 1 hepatorenal syndrome. This new candidate is being developed for ascites as a result of chronic liver cirrhosis.

“Reducing ascites formation promises to improve patients’ quality of life and potentially avoid certain life-threatening complications,” according to the site.

BioVie said clinical trials of BIV201 in the United States could start in 2017. At that time, BioVie will explore the possibility of BIV201 treating other complications from cirrhosis, such as hyponatremia and hepatorenal syndrome. – by Janel Miller

Disclosure: Adams is employed by BioVie.