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.