On June 27, 2023, UCB - A multinational biopharmaceutical company based in Belgium announced that their Rystiggo (rozanolixizumab-noli) has been approved by The US Food and Drug Administration (FDA) for the treatment of adult patients with Generalized Myasthenia Gravis (gMG) who are positive in the antibody anti-muscle-specific tyrosine kinase (MuSK) or anti-acetylcholine receptor (AChR).
gMG is a progressive autoimmune disease that impacts the neuromuscular system of the body. The symptoms vary greatly for each patient, and hence there is no cure for this disease so far. However, clinical trials and history have indicated that several different types of treatments can help reduce the symptoms in gMG and help remission.
The latest addition to treatment options is the FDA-approved Rystiggo.
The President and Chief Executive Officer of the Myasthenia Gravis Foundation of America (MGFA) – Samantha Masterson, also commented on this huge development, saying - "We want to thank UCB for their continued commitment to the MG community to bring a new FDA-approved treatment option for generalized myasthenia gravis to patients and their treating physicians"
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Rystiggo is a humanized igG4 monoclonal antibody that can be administered through a subcutaneous injection for infusion. It works by binding to the neonatal Fc receptor (FcRN) and slowing down the IgG antibody, which is the driving factor behind gMG.
It will allow for more patients of gMG to be treated effectively, specifically, those who are anti-muscle-specific tyrosine kinase (MuSK) or anti-acetylcholine receptor (AChR) antibody positive.
The approval for Rystiggo comes after it showed positive results in clinical trials, including an improvement in Myasthenia Gravis-Activities of Daily Living – which is a scale used to evaluate the symptoms of gMG. Moreover, there was a noticeable decrease in the quantitative myasthenia gravis score – a scale to evaluate muscle weakness in gMG patients.
Currently, AstraZeneca is leading the gMG treatment space with their Ultomiris (ravulizumab-cwvz) and Soliris (eculizumab). argenx’s VYVGART® Hytrulo (efgartigimod alfa and hyaluronidase-qvfc) is another treatment option available for gMG. Additionally, UCB owns Zilucopan and their newly approved Rystiggo.
It will be interesting to see how Rystiggo fares up against the existing treatment options in the market, and how it impacts the patients of gMG. Rystiggo will be commercially available in the third quarter of 2023 in the US.