Imaavy (nipocalimab)

Additional monitoring

Region: 🇪🇺 EU
Active substance: nipocalimab
Company: Janssen Cilag International NV
Status: Authorised
Therapeutic area: Myasthenia Gravis
CHMP opinion: Mon 03 Nov 2025
EU approval: Fri 28 Nov 2025
Designations: Additional monitoring
Application: EMEA/H/C/006379
ATC: L04AL03
Official record: www.ema.europa.eu

Indication

Imaavy is indicated as an add-on to standard therapy for the treatment of generalised myasthenia gravis (gMG) in adult and adolescent patients aged 12 years of age and older who are anti‑acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive.

Regulatory milestones

Fri 28 Nov 2025🇪🇺 EU approval (EC decision)

Imaavy (nipocalimab) approved in the EU

Marketing authorisation to Janssen Cilag International NV; Additional monitoring · source

Mon 03 Nov 2025🇪🇺 CHMP positive opinion

Imaavy (nipocalimab): CHMP positive opinion

Janssen Cilag International NV; Additional monitoring · source

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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.