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FDA supports acute liver failure treatment

The FDA has announced that Digna Biotech's cardiotrophin-1 (CT-1) has been granted orphan drug status for the treatment of acute liver failure

The US Food and Drug Administration (FDA) have announced that Digna Biotech's cardiotrophin-1 (CT-1) has been granted orphan drug status for the treatment of acute liver failure. The FDA grants orphan drug status to medicines to be used in the treatment of rare diseases and conditions.

The Spanish biotechnological company's treatment is expected to work the same way as naturally occurring CT-1 which is actively produced in the liver as part of the defence mechanism against injury. It acts as a chemical messenger in the blood to the damaged liver cells, helping them to recover and restore their function. In the blood, CT-1 has antioxidant (a molecule that prevents the oxidation of other molecules) and anti-inflammatory properties.

Digna Biotech and Biotecnol have co-developed CT-1 for use in organ transplantation and tissue regeneration. An exclusive license and option agreement with Genentech (a fully owned subsidiary of the Roche Group) was signed by both companies in September 2009, with pre-clinical and clinical development funded by private and public entities in Spain.

Acute liver failure has an incidence of around 2,000 cases per year in the US according to a report by the Acute Liver Failure Study Group (ALFSG). It is manifested by the sudden loss of the normal liver functions, in a previously normal liver that has no evidence of chronic liver disease. It can cause jaundice, cerebral oedema (swelling around the brain), convulsions (fits) and a coma. The common causes are toxic damage (eg alcohol and drugs such as paracetamol) or viral hepatitis (an infectious disease that affects the liver). It is a long-term debilitating and life-threatening disease because of its damaging effects on the brain and other organs.

22nd September 2011


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