Genentech announced that the Food and Drug Administration (FDA) has approved ACTPen autoinjector for Actemra (tocilizumab) as a new formulation for adults with moderate to severe active rheumatoid arthritis (RA) who have had an inadequate response to 1 or more disease-modifying anti-rheumatic drugs (DMARDs), and for adults with giant cell arteritis (GCA). In addition, for patients aged ≥2 years with polyarticular juvenile idiopathic arthritis (PJIA) or active systemic juvenile idiopathic arthritis (SJIA), ACTPen can be administered by caregivers; the autoinjector has not been tested for self-injection in pediatric patients.
The FDA approval of the ACTPen was supported by data from 2 studies: an open-label, randomized, 2-period, crossover Phase 1 study (N=188), and an open-label, non-randomized, observational Phase 4 human factors study (N=54). The Phase 1 study assessed the relative bioavailability of a single injection of Actemra 162mg SC via the prefilled syringe with needle safety device vs a single injection via the ACTPen. Results showed that the single-dose SC inj of Actemra with the ACTPen was bioequivalent to administration with the currently marketed prefilled syringe.
The Phase 4 study looked at whether the ACTPen could be used safely and effectively by patients, caregivers or healthcare professionals to administer the injection. Users in the study were able to perform the tasks required to successfully administer Actemra.
Actemra, an interleukin-6 (IL-6) receptor antagonist, was initially approved as an intravenous (IV) infusion formulation for adults with RA in 2010. The prefilled syringe formulation for subcutaneous (SC) injection was later approved in 2013. ACTPen is anticipated to launch in January 2019 as a 162mg/0.9mL strength single-dose prefilled pen. “With ACTPen for Actemra, we are pleased to offer an additional option to patients who may prefer using the new autoinjector over other formulations,” said Sandra Horning, MD, chief medical officer and head of Global Product Development
For more information call (800) 821-8590 or visit Actemra.com.