Swedish pharmaceutical company Calliditas Therapeutics AB (publ) revealed on Tuesday the receipt of US Food and Drug Administration (FDA) orphan drug designation (ODD) for the treatment of primary biliary cholangitis (PBC), previously known as primary biliary cirrhosis.

PBC is reportedly an autoimmune disease of the liver, where common symptoms are tiredness, itching and, in more advanced cases, jaundice. PBC is a rare disease, affecting approximately 4.3 people in 10,000 in US and is much more common in women.

In consultation with the US FDA, the company plans to discuss the regulatory pathway for PBC and investigate the most appropriate way forward for this patient population.

The US FDA Orphan Drug Act (ODA) reportedly provides for granting special status to a drug or biological product to treat a rare disease that affect fewer than 200,000 people in the US. Orphan drug designation qualifies the sponsor of the drug for various development incentives of the ODA, including tax credits, protocol assistance and up to seven years of US marketing exclusivity from time of approval of a Biologics License Application (BLA).