UCB — Rystiggo EMA EPAR public assessment report (EMEA/H/C/005824, 2024)
UCB · 2024 · EMA EPAR public assessment report · company profile →
Report summary
This EMA report assesses Rystiggo (rozanolixizumab) for generalized myasthenia gravis (gMG), an anti-FcRn monoclonal antibody. It details the regulatory process, manufacturing, quality control, and non-clinical studies confirming its mechanism and safety. Pharmacokinetic/pharmacodynamic modeling informed dosing, with clinical trials (MG0003, MG0007) demonstrating significant efficacy in improving gMG symptoms (MG-ADL, MG-Composite, QMG scores) at Day 43 for both 7mg/kg and 10mg/kg doses. Safety analysis revealed common adverse events like headache and infections, with higher incidence and severity at the 10mg/kg dose, leading to a recommended 7mg/kg regimen. The report concludes with a comprehensive risk management plan.
Key findings — cited to the page
| Recommended weekly dose of Rystiggo for body weight ≥ 100 kg | 840 mg | Rystiggo · p.13 |
| Scientific advice received from CHMP for rozanolixizumab development | 16/12/2021 | rozanolixizumab · p.13 |
| Scientific advice received from CHMP for rozanolixizumab development | 29/05/2019 | rozanolixizumab · p.13 |
| Concentration of rozanolixizumab in finished product | 140 mg/mL | · p.14 |
| Amount of rozanolixizumab per vial | 280 mg | · p.14 |
| Shelf life of rozanolixizumab active substance | 36 months | rozanolixizumab · p.21 |
| Protein concentration | 140 mg/mL | · p.22 |
| Strength | 280 mg/2 mL | · p.22 |
| Commitment to develop quantitative assay for free fatty acids | Q4 2024 | · p.22 |
| Commitment to investigate PS80 adsorption | end Q4 2024 | · p.22 |
| Shelf life | 24 months | · p.25 |
| Recommended weekly dose of Rystiggo for body weight ≥ 70 to < 100 kg | 560 mg | Rystiggo · p.13 |
Source: UCB ↗ · License: EMA - reuse permitted with acknowledgement. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Immunology library →