RYSTIGGO®▼ (rozanolixizumab) EC approval

Posted on 8 January, 2024 - Myasthenia Gravis

UCB announces European Commission approval of RYSTIGGO®▼ (rozanolixizumab) for the treatment of adults with generalized myasthenia gravis in Europe

  • European approval of RYSTIGGO® (rozanolixizumab) granted as an add-on to standard therapy for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive1
  • Approval of this orphan medicinal product is based on pivotal Phase 3 MycarinG study in gMG,2 which demonstrated that treatment with rozanolixizumab resulted in statistically significant and clinically meaningful improvements in gMG-specific outcomes compared to placebo,2 including everyday activities such as breathing, talking, swallowing, and being able to rise from a chair3
  • Rozanolixizumab is the first therapy approved in Europe for adults with AChR or MuSK antibody-positive gMG, the two most common subtypes of gMG 
  • The decision follows EC approval for UCB’s ZILBRYSQ®▼ (zilucoplan) in Europe for the treatment of adult patients with gMG, alongside U.S. FDA and Japanese MHLW approvals of rozanolixizumab and zilucoplan for the treatment of gMG in adult patients in 2023.4,5,6,7
  • UCB is the first and only company to offer a gMG-focused portfolio, that provides patients and clinicians the option of targeted therapies for both anti-AChR and anti-MuSK antibody-positive gMG

8th January 2024: UCB, a global biopharmaceutical company, today announced that the European Commission (EC) granted a marketing authorisation for RYSTIGGO® (rozanolixizumab) on 5th January 2024 as an add-on to standard therapy for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) or anti-muscle-specific tyrosine kinase (MuSK) antibody positive1.

Rozanolixizumab 140 mg/ml solution for injection is a humanised IgG4 monoclonal antibody that binds to the neonatal Fc receptor (FcRn) resulting in the reduction of circulating IgG.2 It is the first therapy approved in Europe for adults with anti-AChR or anti-MuSK antibody-positive gMG, the two most common subtypes of gMG.

In December 2023, the EC also granted a marketing authorisation for UCB’s ZILBRYSQ®▼(zilucoplan) as an add-on to standard therapy for the treatment of gMG in adult patients who are anti-AChR antibody-positive4. Zilucoplan is a once-daily subcutaneously (SC) injected, self-administered peptide inhibitor of complement component 5 (C5 inhibitor).8

In progressing a portfolio of medicines for the treatment of gMG, with the aim of providing HCPs the option of addressing either complement activation or pathogenic antibodies for appropriate patients, UCB hopes to offer a comprehensive portfolio of targeted therapeutics, embodying a commitment to addressing the gMG community’s unmet needs.

With the EC approval of rozanolixizumab, alongside their recent approval of zilucoplan, I’m very excited that our gMG portfolio is now approved for use by healthcare professionals across Europe. This represents another important milestone in our ambition to deliver new and additional patient value to the gMG community and continues our launch trajectory. We believe there is still a significant unmet need within the gMG community which can be addressed by bringing differentiated, generally well-tolerated, and effective treatment options to patients that address key aspects of gMG pathophysiology.

Jean-Christophe Tellier, CEO, UCB

EC approval of rozanolixizumab is supported by safety and efficacy data from the pivotal Phase 3 MycarinG study (NCT03971422), published in The Lancet Neurology in May 2023.2

This announcement follows approvals of rozanolixizumab and zilucoplan by the Japanese Ministry of Health, Labour and Welfare (MHLW) for treatment of gMG in adult patients (only for patients who inadequately respond to steroids or other immunosuppressants), approval of rozanolixizumab by the U.S. Food and Drug Administration (FDA) for the treatment of gMG in adult patients who are anti-AChR or anti-MuSK antibody positive , and approval of zilucoplan by the FDA for the treatment of gMG in adult patients who are AChR antibody-positive. 7,5,6

Orphan designation was granted by the European Commission in 2020 to rozanolixizumab for the treatment of myasthenia gravis and maintained after having received the positive CHMP Opinion.9

The approval of rozanolixizumab from the EC is valid in all EU member states, as well as in the European Economic Area (EEA) countries Iceland, Liechtenstein, and Norway. 

UCB is committed to making rozanolixizumab available to patients as quickly as possible and anticipates European availability will commence in the first quarter of 2024.

▼ This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions.

References:

  1. Rozanolixizumab EU SmPC https://www.ema.europa.eu/en. Accessed January 2024.
  2. Bril V. Efficacy and safety of rozanolixizumab in patients with generalised myasthenia gravis: a randomised, double-blind, placebo-controlled, adaptive Phase 3 study MycarinG study. Lancet Neurol. 2023;22(5):383-94.
  3. Wolfe Gl, et al. Myasthenia gravis activities of daily living profile. Neurology. 1992;52(7):1487-9.
  4. Zilucoplan EU SmPC https://www.ema.europa.eu/en/documents/product-information/zilbrysq-epar-product-information_en.pdf. Accessed January 2024.
  5. RYSTIGGO® U.S. Prescribing Information https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/761286s000lbl.pdf. Accessed January 2024.
  6. ZILBRYSQ® U.S. Prescribing Information. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/216834s000lbl.pdf. Accessed January 2024
  7. Japan MHLW, 25 September 2023.
  8. Howard JF Jr, et al. Safety and efficacy of zilucoplan in patients with generalised myasthenia gravis (RAISE): a randomised, double-blind, placebo-controlled, phase 3 study. Lancet Neurol. 2023;22(5):395-406. 
  9. European Medicines Agency. 2020. EU/3/20/2272: Orphan designation for the treatment of myasthenia gravis. https://www.ema.europa.eu/en/medicines/human/orphan-designations/eu3202272. Accessed January 2024.

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