Basic Information
Elfabrio
Regulatory Information
EMEA/H/C/005618
May 4, 2023
February 23, 2023
2
November 20, 2024
Company Information
Italy
Via Palermo 26/A 43122 Parma
CHIESI FARMACEUTICI S.P.A.
Active Substances Detail
EMA Resources
Detailed Information
Therapeutic Indication
### Therapeutic indication Elfabrio is indicated for long-term enzyme replacement therapy in adult patients with a confirmed diagnosis of Fabry disease (deficiency of alpha-galactosidase).
Overview Summary
Elfabrio is a medicine used in adults to treat Fabry disease, a rare inherited disorder. Patients with Fabry disease do not have enough of an enzyme, called alpha-galactosidase A, that normally breaks down a fatty substance called globotriaosylceramide (Gb3). If the enzyme is not present, Gb3 cannot be broken down and it builds up in the organs, such as the kidney and heart, causing kidney failure and heart problems. Elfabrio contains the active substance pegunigalsidase alfa.