Digna Biotech, a Spanish biotechnological company, announces that the Food and Drug Administration (FDA) granted cardiotrophin-1 (CT-1) Orphan Drug status for use in the treatment of acute liver failure (Designation request 11-3507).
This provides more incentives to work on cures for this disease, which has an incidence of 2,000 cases per year in the United States, according to the findings reported by Acute Liver Failure Study Group (ALFSG) (Lee, Squires et al. 2008). In August, the European Medicine Agency (EMA) granted also the Orphan Drug status of cardiotrophin-1 for the treatment of acute liver failure (EU/3/11/893).
Pablo Ortiz, CEO at Digna Biotech, commented, "The experimental findings that support this new indication of CT-1 are very strong and we are confident that they can be converted in a clinical valuable effect in patients suffering from acute liver failure of different etiology. Acute liver failure is a very severe condition with a high mortality rate and very limited therapeutics possibilities that needs effective treatments. The advantage of having the product at the clinical stage starting Phase I allow us to plan Phase II for this indication by the end of next year."
Acute liver failure is a rare disease that is manifested by a sudden loss of the normal liver functions in a patient with a previously normal liver and without evidence of chronic liver disease. The most common first sign of liver failure is yellowing of the skin (jaundice). This condition has serious complications such as bruising and bleeding due to impaired blood clotting as well as cerebral edema (swelling around the brain), convulsions (fits) and coma. The most common causes of acute liver failure are toxic damage (e.g. alcohol and drugs such as paracetamol) or viral hepatitis (an infectious disease that affects the liver). Acute liver failure is a long-term debilitating and life-threatening disease because of its damaging effects on the brain a
|Contact: Nuria Safont|
Digna Biotech S.L