aTyr wins EU orphan drug status for lead asset in systemic sclerosis

• aTyr Pharma (NASDAQ:LIFE) announced Thursday that the European Commission issued the orphan drug designation for its lead candidate, efzofitimod, as a treatment for the autoimmune condition systemic sclerosis.
• The decision aligns with the suggestions from the Committee for Orphan Medicinal Products of the EU drug regulator, the European Medicines Agency (EMA).
• Efzofitimod is currently undergoing a global pivotal Phase 3 clinical trial for pulmonary sarcoidosis, and a Phase 2 proof-of-concept study for the candidate is expected to begin in Q3 2023 for systemic sclerosis-interstitial lung disease.
• The benefits of the EU's orphan drug designations include a potential ten-year marketing exclusivity following a regulatory nod for those drugs in the region.
• Systemic sclerosis, marked by inflammation and fibrosis of connective tissues, is estimated to affect about 100K people in the EU.

More on aTyr

• ATyr Pharma therapy for lung disorder gets orphan drug status in EU
• aTyr Pharma: The Uncertainty Of Efzofitimod, Analysis Of Clinical Study