Experimental Hepatorenal Syndrome Drug Gets Orphan Drug Designation

According to a story from accesswire.com, the drug developer BioVie, Inc., recently announced that the US Food and Drug Administration (FDA) has granted Orphan Drug designation to the company’s investigational drug candidate BIV201, also known as terlipressin. The designation is for treating hepatorenal syndrome. BioVie is committed to the development of treatments for diseases of the liver.

About Hepatorenal Syndrome

Hepatorenal syndrome is a potentially fatal disease in which kidney function rapidly declines in patients with cirrhosis or liver failure. Patients with severe alcoholic hepatitis may also be affected. The most definitive risk factor for hepatorenal syndrome is prior liver disease or the complications that may result from it, such as portal hypertension, cirrhosis, acute liver failure, bacterial infection, bleeding in the upper digestive tract, or infection of the ascites fluid. Symptoms include jaundice, kidney failure, abnormal liver function, swollen abdomen, and hepatic encephalopathy. Treatment options may include liver transplant, certain medications, or dialysis to prevent disease progression. Preventative treatment is essential as risk of death is quite high; doctors often attempt to identify patients that are at risk and take measures to avoid possible triggering events like infection. Patients without access to treatment will die quickly. To learn more about hepatorenal syndrome, click here.

About Orphan Drug Designation

Orphan Drug designation is usually reserved for therapies designed to treat diseases or conditions that are considered rare, which is defined as any disease that affects less than 200,000 people in the US. A drug must also offer considerable advantages either in safety or effectiveness over currently available therapies or must address a currently unmet medical need. Orphan Drug designation confers several benefits to the recipient company, such as tax breaks, the waiving of certain fees, and a seven year period of market exclusivity if the product is approved for public use.

About BIV201

BIV201 is in the midst of a Phase 2a clinical trial which is testing the therapy as a treatment for refractory ascites which occurs as a result of cirrhosis. This disease is a common precursor to hepatorenal syndrome. The drug has also been granted Orphan drug designation for the treatment of ascites. BIV201 has the potential to treat a number of serious liver complications.


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