A Randomized, Double-Blind, Multiple-Dose, Parallel-Group, Two-Arm Study to Evaluate the Efficacy, Safety and Immunogenicity of MSB11456 Compared to European Union approved RoActemra in Patients with Moderately to Severely Active Rheumatoid Arthritis (APTURA I study)
Latest Information Update: 28 Feb 2025
At a glance
- Drugs Tocilizumab (Primary)
- Indications Rheumatoid arthritis
- Focus Registrational; Therapeutic Use
- Acronyms APTURA I
- Sponsors Fresenius Kabi
Most Recent Events
- 07 Mar 2024 According to a Fresenius Kabi Media Release, US FDA has approved Tyenne (tocilizumab-aazg), a biosimilar referencing tocilizumab (Actemra; Genentech), for the treatment of multiple autoimmune diseases, including rheumatoid arthritis and juvenile idiopathic arthritis.
- 15 Nov 2023 Results comparing the efficacy, safety, and immunogenicity of MSB11456 and EU approved tocilizumab administered SC , presented at the ACR Convergence 2023
- 21 Jul 2023 According to a Fresenius Kabi Media Release, MSB11456, has received a positive recommendation for a marketing authorization from the European Medicines Agencys (EMA) Committee for Medicinal Products for Human Use (CHMP).