Orphan drug status is granted to drug candidates that are developed for severe, disabling diseases for which there are currently no satisfactory products on the market. Moreover, a condition for granting orphan drug status is that the disease is rare and exists in less than five out of 10,000 citizens in the EU.
Orphan drug status for the drug, ASF-1096, may involve major benefits to Astion, the company said, including reduced costs in connection with European Agency for the Evaluation of Medicinal Products (EMEA) filings, regulatory assistance and a faster, more flexible application process.
“With the orphan drug status we have taken an important step towards bringing ASF-1096 into an optimal development process towards commercialization,” said Lars Smedegaard Andersen, CEO.
ASF-1096 is in clinical phase II, and Astion Pharma expects to bring the drug candidate into phase III within 6-12 months. Astion Pharma expects to file an application for orphan drug status with the US authorities in August 2007.
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