Food and Drug administration (FDA) has declared orphan drug designation for Amryt Pharma’s leading treatment therapy Episalvan for the treatment of epidermolysis bullosa (EB). It is a rare and distressing genetic disorder affecting young children to have a highly fragile skin. Currently, the pharmaceutical company is planning to carry out Phase-3 clinical trial to assess its potential to accelerate the healing process in emidermolysis bullosa.
The firm claims that the product is already available in the market to treat gash or ulcers also referred as partial thickness wound in adults. Episalvan is a skin treatment therapy for kids and adults. The results from other clinical trials have been encouraging. The skin treatment therapy has been awarded with the orphan drug status in United States by FDA and Europe by European Commission.
Orphan drug designation is granted by Food and Drug administration and European Commission to the drugs and treatments or therapies that claims to have the cures of rare diseases. These rare diseases are defined as the diseases affecting less than 20,000 people in a country. These diseases have do not have common treatment methods or other medicinal cures and are incurable and severe in nature which may cause death. FDA and EU Commission address the need of such patients suffering from rare diseases by granting orphan drug status to these medications and treatments. Additionally, these authorities provide certain incentives and relaxation in the fees to the companies producing these drugs.
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