Home » EMEA Recommends Orphan Drug Status for ASF-1096
EMEA Recommends Orphan Drug Status for ASF-1096
The European Medicines Agency (EMEA) recommended that Astion’s ASF-1096 be granted orphan drug status for the treatment of cutaneous lupus erythematosus (CLE).
CLE is a chronic skin condition characterized by severe, inflamed lesions in the skin. These lesions may be active for several months or years and in some cases leave significant scarring and/or pigmentary changes and permanent hair loss.
ASF-1096 is in clinical Phase II, and the company said it expects to bring the drug candidate into Phase III within six-12 months.
Astion said it expects to file an application for orphan drug status with the FDA this month.
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