PARIS (dpa-AFX) - Sanofi (SNY, SNYNF, SAN.PA) announced that the European Medicines Agency (EMA) has granted orphan designation to efdoralprin alfa (SAR447537), formerly known as INBRX-101.
Efdoralprin alfa is an investigational recombinant human alpha-1 antitrypsin (AAT)-Fc fusion protein. It is being developed as a potential treatment for alpha-1 antitrypsin deficiency (AATD)-related emphysema, a rare and serious respiratory condition.
The designation highlights the significant unmet medical need in AATD-related emphysema and underscores the potential of efdoralprin alfa to provide new therapeutic options for patients affected by this condition.
The US Food and Drug Administration previously granted both fast track and orphan drug designation to efdoralprin alfa for the treatment of AATD related emphysema.
Efdoralprin alfa is currently in clinical development, and its safety and efficacy have not been evaluated by any regulatory authority. Sanofi plans to present the data at a forthcoming medical meeting and engage with global regulatory authorities on the appropriate next steps.
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