The National Institute for Health and Care Excellence (NICE) has recommended Rystiggo (rozanolixizumab) as a treatment for adults with antibody-positive generalised myasthenia gravis (gMG). 

Rystiggo is the first targeted therapy for gMG, a rare, chronic autoimmune neuromuscular disease. The condition is characterised by fluctuating muscle weakness and fatigue and can lead to difficulties with vision, speech, swallowing, breathing and mobility. The disease subsequently places a substantial physical, emotional and practical burden on patients and their families. 

NICE’s recommendation of Rystiggo, developed by biopharmaceutical company UCB, is the first in myasthenia gravis via the Single Technology Appraisal Route and one of the first medicines recommended under NICE’s new Quality-Adjusted Life Year (QALY) thresholds. 

The approval was based on the Phase III 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. 

“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.” 

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

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