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FDA Approves Prefilled Autoinjector for Actemra
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The FDA has approved ACTPen, a single-dose prefilled autoinjector of tocilizumab, for the treatment of adult patients with moderate to severe active rheumatoid arthritis who failed to respond to one or more disease-modifying antirheumatic drugs, and for adult patients with giant cell arteritis, according to a company press release.
Additionally, this formulation of tocilizumab (Actemra, Genentech) is approved for use by caregivers of patients aged 2 years and older with active polyarticular juvenile idiopathic arthritis or active systemic juvenile idiopathic arthritis.
“When it comes to the administration of medicines, we believe patients should have choices, when possible,” Sandra Horning, MD, chief medical officer and head of global product development for Genentech, said in the release. “With ACTPen for Actemra, we are pleased to offer an additional option to patients who may prefer using the new autoinjector over other formulations.”
The FDA based its approval on two clinical datasets presented at the 2018 American Society for Clinical Pharmacology & Therapeutics Annual Meeting. The first dataset included an open-label, randomized, two-period, crossover phase 1 study of 188 healthy volunteers, comparing the relative bioavailability of a single injection of subcutaneous tocilizumab 162 mg via the pre-filled syringe with needle safety device, with a single injection of subcutaneous tocilizumab 162 mg via the autoinjector.
The second dataset included an open-label, nonrandomized, observational phase 4 human factors study of 54 patients with RA, examining if the autoinjector could be used safely and effectively by patients, caregivers or health care professionals to administer the tocilizumab injection.
According to the combined study results, the single-dose subcutaneous administration of 162 mg tocilizumab with the autoinjector was bioequivalent to administration with the currently marketed pre-filled syringe, and the intended users of the autoinjector were successful in performing the tasks required to administer doses of tocilizumab.
The most common adverse reactions in both studies — consistent with the established safety profile for tocilizumab — included diarrhea, headache, nasopharyngitis and upper respiratory tract infections, as well as reports of increased risk for serious infections.