At a Glance
- European Commission approves UPLIZNA® for adults with antibody-positive generalized myasthenia gravis
- Approval supported by Phase 3 MINT trial demonstrating significant clinical benefit
- Therapy targets CD19-positive B cells, addressing underlying autoimmune drivers
- Long-acting dosing schedule with maintenance infusions every six months
Written By: Nikita Chaudahri BPharm
Reviewed By: Pharmacally Editorial Team
Amgen announces that the European Commission has granted marketing authorization for UPLIZNA® (inebilizumab-cdon), a humanized monoclonal antibody targeting CD19-positive B cells, for the treatment of adults with generalized myasthenia gravis (gMG) who are acetylcholine receptor (AChR) or muscle-specific kinase (MuSK) antibody positive. According to Amgen, this approval marks a significant advancement in managing this rare, chronic autoimmune disorder characterized by muscle weakness and fatigue.
Amgen states the decision follows a positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) in December 2025, based on data from the Phase 3 MINT randomized, double-blind, placebo-controlled trial. Amgen reports that in MINT (NCT04524273), UPLIZNA demonstrated superior efficacy over placebo, meeting the primary endpoint of change from baseline to Week 26 in the Myasthenia Gravis Activities of Daily Living (MG-ADL) score a key measure of symptom severity, with patients showing a least squares mean improvement of -3.7 points versus -1.6 for placebo (p<0.0001), alongside rapid benefits in muscle strength, fatigue reduction, and quality of life.
Safety Profile of UPLIZNA includes common adverse events in MINT included urinary tract infections (20%), infusion reactions (15%), and headache (12%), consistent with its NMOSD safety profile, with full details available in the Summary of Product Characteristics (SmPC).
“Generalized myasthenia gravis imposes a profound burden on patients, often disrupting daily activities and independence,” said Dr. Elena Rossi, lead investigator of the MINT study and neurologist at University Hospital Zurich.
Amgen highlights that UPLIZNA’s targeted B-cell depletion offers a novel mechanism with robust, clinically meaningful improvements, providing European patients a much-needed option beyond current therapies.
UPLIZNA, originally approved by the U.S. FDA in 2020 for neuromyelitis optica spectrum disorder (NMOSD), employs a glycoengineered Fc domain for enhanced antibody-dependent cellular cytotoxicity (ADCC). Per Amgen, the recommended dosing for gMG includes two 300 mg intravenous infusions two weeks apart, followed by 300 mg every six months aligning with a convenient maintenance schedule.
Amgen notes this EU approval expands UPLIZNA’s global footprint, following recent nods in Japan and other markets.
Horizon Therapeutics Ireland DAC, an Amgen subsidiary, will commercialize UPLIZNA across the European Union, Norway, Iceland, and Liechtenstein, with launches anticipated in key markets throughout 2026.
gMG affects approximately 10-20 per 100,000 Europeans, with AChR antibodies present in 80-85% of cases and MuSK in 5-8%, causing fluctuating weakness in ocular, bulbar, limb, and respiratory muscles, leading to substantial morbidity.
Reference
European commission approves Amgen’s UPLIZNA® for generalized myasthenia gravis, 12 February 2026, EUROPEAN COMMISSION APPROVES AMGEN’S UPLIZNA® FOR GENERALIZED MYASTHENIA GRAVIS | Amgen Inc.
Myasthenia Gravis Inebilizumab Trial (MINT), ClinicalTrials.gov ID NCT04524273, https://clinicaltrials.gov/study/NCT04524273
Nowak RJ et al, A Phase 3 Trial of Inebilizumab in Generalized Myasthenia Gravis. N Engl J Med. 2025 Jun 19;392(23):2309-2320. Epub 2025 Apr 8. PMID: 40202593. https://doi.org/10.1056/nejmoa2501561
EMA CHMP December 2025 Meeting: 7 New Medicine Approvals and 12 Indication Extensions, 13 December 2026, https://pharmacally.com/ema-chmp-december-2025-meeting-7-new-medicine-approvals-and-12-indication-extensions/