pegunigalsidase alfa pegunigalsidase alfa pegunigalsidase alfa, sold under the brand name elfabrio, is an enzyme replacement therapy for the treatment of fabry disease. it is a recombinant human α-galactosidase-a. it is a hydrolytic lysosomal neutral glycosphingolipid-specific enzyme. pegunigalsidase alfaclinical datatrade nameselfabrioother namesprx-102, pegunigalsidase alfa-iwxjlicense data us dailymed: pegunigalsidase alfa routes ofadministrationintravenousatc codea16ab20 (who) legal statuslegal status us: ℞-only eu: rx-only identifierscas number1644392-61-9drugbankdb14992unii8m7v7q6537keggd11685chemical and physical dataformulac2060h3130n552o601s27molar mass46110.58 g·mol−1 the most common side effects are infusion-related reactions, hypersensitivity and asthenia. pegunigalsidase alfa was approved for medical use in both the european union and the united states in may 2023. medical uses pegunigalsidase alfa is indicated for long-term enzyme replacement therapy in aduls with a confirmed diagnosis of fabry disease (deficiency of alpha-galactosidase). society and culture legal status on 23 february 2023, the committee for medicinal products for human use (chmp) of the european medicines agency (ema) adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product elfabrio, intended for the treatment of fabry disease. the applicant for this medicinal product is chiesi farmaceutici s.p.a. elfabrio was approved for medical use in the european union in may 2023.