National Institute for Health and Care Excellence recommends rozanolixizumab as the first targeted treatment for adults with uncontrolled generalized myasthenia gravis, with NHS access via interim funding.
Written By: Vennela Reddy, BPharm
Reviewed By: Pharmacally Editorial Team
The National Institute for Health and Care Excellence (NICE) has issued final draft guidance recommending rozanolixizumab as a new treatment option for adults with uncontrolled generalized myasthenia gravis (gMG).
The recommendation, published on 29 April 2026, marks the first time NICE has endorsed this therapy for patients whose symptoms remain inadequately controlled with standard treatments.
NICE recommends rozanolixizumab for adults who test positive for anti-acetylcholine receptor (AChR) or muscle-specific kinase (MuSK) antibodies and continue to experience poorly controlled disease despite standard therapies, including corticosteroids. Around 800 patients in England are expected to be eligible.
Rozanolixizumab, developed by UCB Pharma, is a monoclonal antibody that targets the neonatal Fc receptor (FcRn), reducing pathogenic immunoglobulin G (IgG) levels. Clinical studies show that adding the therapy to existing treatment regimens reduces symptom severity and improves patients’ ability to perform daily activities.
Experts consulted by NICE noted that even modest clinical improvements can significantly enhance independence, wellbeing, and quality of life in this population.
Patients with uncontrolled gMG often require treatments such as intravenous immunoglobulin (IVIg) or plasma exchange (PLEX), which typically involve frequent hospital visits or inpatient care. In contrast, rozanolixizumab is administered as a short course of subcutaneous injections and can be supported through homecare services, enabling self-administration in many cases.
This administration approach may reduce disruption to work and family life, lessen caregiver burden, and improve mental wellbeing for patients who find hospital-based treatments challenging. Improved disease control may also allow some patients to reduce long-term corticosteroid use, potentially lowering the risk of associated adverse effects.
According to Helen Knight, Director of Medicines Evaluation at NICE, the draft recommendation represents an important step forward for patients with gMG whose disease remains uncontrolled, offering a targeted treatment option with the potential to improve symptoms and daily functioning.
Generalized myasthenia gravis is a rare, chronic autoimmune disease characterized by muscle weakness and fatigue. The condition can impair breathing, speech, swallowing, vision, and mobility, with symptoms that often fluctuate unpredictably and may require repeated hospital care. There is currently no cure.
The therapy will be made available immediately on the National Health Service (NHS) in England through interim funding from the Innovative Medicines Fund. Final NICE guidance is expected to be published in the coming month following agreement on a commercial access arrangement between NHS England and UCB Pharma.
References
First NICE recommended treatment for uncontrolled generalised myasthenia gravis | NICE
