Calliditas Therapeutics granted orphan drug designation by the FDA for Primary biliary cholangitis
Calliditas Therapeutics AB (publ) (”Calliditas”) today announced that the US Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to the company for the treatment of Primary biliary cholangitis (PBC). More information about the ODD has been posted on www.fda.gov.PBC, previously known as primary biliary cirrhosis, is 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. It is much more common in women, with a ratio of at least 9: