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NICE recommends UCB’s RYSTIGGO▼ (rozanolixizumab) for adults with antibody-positive generalised myasthenia gravis in Final Draft Guidance

April 29, 2026 – Biotechnology, Clinical Trials, Drug Discovery, Other, Pharmaceutical – Final Draft Guidance, NICE, UCB Pharma, antibody-positive generalised myasthenia gravis, neurology

Rozanolixizumab, discovered and developed in the UK, has been recommended by NICE as an add on treatment option for eligible adults with antibody-positive generalised myasthenia gravis (gMG)
Recommendation represents three firsts: first recommendation for targeted therapy for gMG; first recommendation in myasthenia gravis via the Single Technology Appraisal route; one of the first medicines recommended under NICE’s new Quality-Adjusted Life Year (QALY) thresholds
The approval is supported by Phase 3 MycarinG study and its open label extension which demonstrated reduced disease severity and improved patients’ ability to carry out daily activities compared with standard treatment alone.

29 April 2026 — Slough, UK — UCB is pleased to announce that the National Institute for Health and Care Excellence (NICE) has issued Final Draft Guidance recommending RYSTIGGO (rozanolixizumab), the first targeted therapy for generalised myasthenia gravis (gMG), a rare and debilitating condition that impacts the daily lives of people living with the condition. This recommendation also represents:

the first NICE recommendation in myasthenia gravis via the Single Technology Appraisal route
one of the first medicines recommended under NICE’s new Quality-Adjusted Life Year (QALY) thresholds.

In addition to this recommendation, rozanolixizumab has received early funding approval via NHS England’s Innovative Medicines Fund (IMF), enabling interim patient access ahead of final guidance and routine commissioning.

“We are pleased that NICE has recognised the value of rozanolixizumab for people living with generalised myasthenia gravis who remain symptomatic despite multiple treatments,” said Nico Reynders, General Manager of UCB UK and Ireland. “This recommendation represents an important step forward in providing access to treatment for eligible patients across the NHS, addressing a long-standing gap in care whilst also providing the possibility for home-based care for the condition, aligning with the NHS 10-Year Health Plan ambitions. We are proud to have worked closely with NICE throughout this process to ensure the evidence was fully understood and the patient need clearly recognised.”

Generalised myasthenia gravis is a rare, chronic autoimmune neuromuscular disease characterised by fluctuating muscle weakness and fatigue. It can affect multiple muscle groups, leading to difficulties with vision, speech, swallowing, breathing and mobility, and can place a substantial physical, emotional and practical burden on patients and their families.

“The profound impact of myasthenia gravis on daily life can often mean people living with the condition have to adjust how they work, how they socialise and importantly, how they manage seemingly simple tasks such as chewing, swallowing and speaking,” said Charlotte Carpenter, Research & Partnerships Manager at Myaware. “There is currently no cure and many patients require long-term, complex treatment regimens. The recommendation of an additional treatment option provides hope for those living with generalised myasthenia gravis and helps bring UK care closer to established standards already seen elsewhere in Europe.”

Under the Final Draft Guidance, rozanolixizumab is recommended as an option for the treatment of adults with gMG who test positive for anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibodies, where the disease is classified as Myasthenia Gravis Foundation of America (MGFA) class II to IVa, remains uncontrolled following two or more treatments (excluding acetylcholinesterase inhibitors), and where intravenous immunoglobulin (IVIg) or plasma exchange (PLEX) would otherwise be offered, or has been tried and halted due to side effects or insufficient effect.

“The NICE recommendation for rozanolixizumab is an important step in the management of generalised myasthenia gravis with the potential to make a real improvement in the lives of patients,” said Professor Saiju Jacob, Consultant Neurologist. “gMG can have a profound impact on daily activities, and having an additional treatment option available will be meaningful for patients living with this complex condition.”
The recommendation is based on evidence from the Phase 3 MycarinG study and its open-label extension, which demonstrated that rozanolixizumab, when added to standard treatment, reduced disease severity and improved patients’ ability to carry out daily activities compared with standard treatment alone.

Clinical trial evidence showed consistent improvements across key measures of disease activity, including the Myasthenia Gravis Activities of Daily Living (MG-ADL) score. Common adverse events reported were headache, diarrhoea, and pyrexia (fever), with most events reported as mild to moderate.

Rozanolixizumab, the fourth medicine to be discovered, developed and made available to patients in the UK and worldwide by UCB, is administered as a short-duration, once-weekly subcutaneous infusion. NICE acknowledged potential additional benefits of treatment, including convenience of administration and the possibility of home-based care delivery, alongside the burden associated with existing hospital-based therapies such as IVIg and PLEX.

About UCB
UCB, Brussels, Belgium is a global biopharmaceutical company focused on the discovery and development of innovative medicines and solutions to transform the lives of people living with severe diseases of the immune system or of the central nervous system. With more than 9,000 people in approximately 40 countries, the company generated revenue of € 7.7 billion in 2025. UCB is listed on Euronext Brussels (symbol: UCB). The UK is one of three global R&D hubs. UCB is listed on Euronext Brussels (symbol: UCB). Follow us on LinkedIn @UCB UK or at www.ucbpharma.co.uk