nipocalimab
Drug Details
- Generic Name
- nipocalimab
- Brand Names
- IMAAVY
- Application Number
- BLA761430
- Sponsor
- Janssen Biotech, Inc.
- NDC Codes
- 2
- Dosage Forms
- INJECTION, SOLUTION, CONCENTRATE
- Routes
- INTRAVENOUS
- Active Ingredients
- NIPOCALIMAB
Indications and Usage
1 INDICATIONS AND USAGE IMAAVY is indicated for the treatment of generalized myasthenia gravis (gMG) in adult and pediatric patients 12 years of age and older who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive. IMAAVY is a neonatal Fc receptor blocker indicated for the treatment of generalized myasthenia gravis (gMG) in adult and pediatric patients 12 years of age and older who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive. ( 1 )