EUNew treatments and approvals
Nipocalimab approved in the EU for myasthenia gravis, including adolescents aged 12 and over
A decision by a medicines regulator (FDA, European Commission, etc.). The regulator has reviewed the clinical studies behind the drug. For accelerated or conditional approvals, the lasting benefit is still being confirmed.
On November 28, 2025, the European Commission approved nipocalimab for generalized myasthenia gravis. The drug is used in patients aged 12 years and older, in addition to their existing treatment. The patient's blood must contain AChR or MuSK antibodies. The drug is given into a vein every two weeks. The main study included 153 patients.
What does it mean for patients and families?
There were few options for adolescents and for people with MuSK antibodies. This approval opens a new path in Europe. Access in Türkiye depends on TİTCK (Turkish Medicines and Medical Devices Agency) and SGK (Social Security Institution) processes.
Source
Avrupa İlaç Ajansı (EMA) · source page
The source page was opened and read on October 7, 2026. Summary prepared by the Doktorclub editorial team and translated from Turkish; it has not yet been reviewed by a physician (a scientific board is being set up).
This page is translated from the Turkish original.
Related disease: Myasthenia gravis (MG)
This page reports a development; it is not a treatment recommendation. Your doctor decides whether a treatment is right for you.