Posted by Michael Wonder on 27 Nov 2018
FDA approves the ACTpen for Genentech’s Actemra, a single-dose, pre-filled auto-injector for the treatment of rheumatoid arthritis, giant cell arteritis and two forms of juvenile arthritis
26 November 2018 - Genentech announced today that the U.S. FDA has approved ACTPen 162 mg/0.9 mL, a single-dose pre-filled auto-injector for Actemra (tocilizumab) as an additional formulation for adult patients with moderate to severe active rheumatoid arthritis who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs, and for adult patients with giant cell arteritis.
Further, the ACTPen can be administered by caregivers to patients two years of age and older with active polyarticular juvenile idiopathic arthritis or active systemic juvenile idiopathic arthritis. The ability of paediatric patients to self-inject with the ACTPen has not been tested. ACTPen is expected to be available in January 2019.
The approval of the ACTPen is based on clinical data from two studies that were presented at the 2018 American Society for Clinical Pharmacology & Therapeutics Annual Meeting. The first was an open-label, randomised, two-period, crossover Phase I study, investigating the relative bioavailability of a single injection of Actemra 162 mg SC via the PFS with needle safety device to a single injection of Actemra 162 mg SC via the ACTPen in 188 healthy volunteers.
