French healthcare company Sanofi S.A. (Euronext Paris:SAN) (Nasdaq:SNY) announced late Tuesday that the European Medicines Agency has granted orphan designation to efdoralprin alfa (SAR447537, formerly known as INBRX-101) for the potential treatment of alpha-1 antitrypsin deficiency (AATD) related emphysema, a rare respiratory condition.

This designation applies to rare, life-threatening or debilitating conditions affecting no more than 5 in 10,000 people in the European Union.

Efdoralprin alfa, an investigational recombinant human alpha-1 antitrypsin Fc fusion protein, met all primary and key secondary endpoints in the global phase 2 ElevAATe study when dosed every three or four weeks, demonstrating superiority versus a plasma-derived standard of care.

The therapy has also received fast track and orphan drug designations from the US Food and Drug Administration and remains in clinical development, with safety and efficacy not yet evaluated by any regulatory authority.

Sanofi said that it plans to present the data at a future medical meeting and engage with regulators on next steps.