EFGARTIGIMOD ALFA

FDA Drug Profile — VYVGART

Drug Details

Generic Name
EFGARTIGIMOD ALFA
Brand Names
VYVGART
Application Number
BLA761195
Sponsor
Lonza Biologics Tuas Pte.Ltd.
NDC Codes
2
Dosage Forms
LIQUID, INJECTION
Routes
INTRAVENOUS
Active Ingredients
EFGARTIGIMOD ALFA

Indications and Usage

1 INDICATIONS AND USAGE VYVGART HYTRULO is indicated for the treatment of adult patients with: generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive chronic inflammatory demyelinating polyneuropathy (CIDP) VYVGART HYTRULO is a combination of efgartigimod alfa, a neonatal Fc receptor blocker, and hyaluronidase, an endoglycosidase, indicated for the treatment of adult patients with: generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AChR) antibody positive ( 1 ) chronic inflammatory demyelinating polyneuropathy (CIDP) ( 1 )