Elfabrio
Elfabrio ingredients
| Active ingredient | Strength |
|---|---|
| Pegunigalsidase Alfa | 5 mg/2.5mL, 20 mg/10mL |
What Elfabrio is used for
The FDA lists the approved uses on the official label (below). In the EU, pegunigalsidase alfa is approved as Elfabrio for:
Elfabrio is indicated for long-term enzyme replacement therapy in adult patients with a confirmed diagnosis of Fabry disease (deficiency of alpha-galactosidase).
EU wording from the European Medicines Agency; US approved uses can differ.
Key facts
- Brand
- Elfabrio
- Generic name
- Pegunigalsidase alfa
- Made by
- Chiesi USA, Inc.
- Forms
- Injection, Solution, Concentrate
- Given
- Intravenous
- FDA approval
- Biologic licence (BLA) BLA761161
- On the US market since
- 2023
Official information
- Elfabrio prescribing information (FDA label) on DailyMed
- MedlinePlus drug information (search for Pegunigalsidase alfa)
Specialist medicine: started and supervised by a specialist doctor or hospital. This page is a plain-language summary of public official information, not medical advice; follow your doctor and the official product information.
Common questions
What is Elfabrio?
Elfabrio (Pegunigalsidase alfa) is a specialist medicine made by Chiesi USA, Inc., approved by the US FDA.
What are the ingredients of Elfabrio?
Elfabrio contains Pegunigalsidase Alfa (5 mg/2.5mL, 20 mg/10mL).
Is Elfabrio approved in Europe?
The same active substance is approved in the EU as Elfabrio.
From the FDA National Drug Code directory (open.fda.gov, public domain) and the European Medicines Agency medicines list. Page made 5 November 2026 by Satya Babu.
← All specialty medicines, USA