The U.S. Food and Drug Administration (FDA) has approved ACTPen, a single-dose, pre-filled autoinjector of Actemra (tocilizumab) to be administered in children 2 and older who have active polyarticular juvenile idiopathic arthritis (PJIA) or active systemic juvenile idiopathic arthritis (SJIA), Genentech, the company marketing Actemra, announced.
The new formulation is expected to be available in the U.S. in January.
Actemra is a medicine based on the active ingredient tocilizumab, a monoclonal antibody with proven anti-rheumatic effects.
The medicine is sold by Genentech, a subsidiary of the Roche group. The FDA first approved Actemra in January 2010 as an intravenous infusion for adults with rheumatoid arthritis, later granting its use in adults with giant cell arteritis and patients 2 and older with active SJIA and active PJIA.
Earlier this year, the FDA approved Actmera’s under-the-skin (subcutaneous) formulation for all these indications.
The approval of ACTPen is based on the positive safety and pharmacokinetics/pharmacodynamics data — a medication’s distribution, metabolism and activity in the body — from two clinical studies.
One was an open-label, randomized, crossover phase 1 study (NCT02678988), evaluating the bioequivalence of a single subcutaneous injection of Actemra 162 mg given through a prefilled syringe (with needle safety device) versus the autoinjector ACTPen in 188 healthy volunteers.
The second was an open-label, non-randomized, observational Phase 4 study (NCT02682823) in 54 adults with rheumatoid arthritis to investigate whether ACTPen could be used safely and effectively by patients, caregivers and health care professionals.
The studies found that a single dose of Actemra with ACTPen was equivalent to giving the medicine via prefilled syringes, and users were successful in administering the needed doses using the autoinjector.
Importantly, the autoinjector was seen to be safe and adverse events reported were consistent with Actemra’s already-established safety profile.
The ability of children to self-inject with the ACTPen has not yet been tested.
“When it comes to the administration of medicines, we believe patients should have choices when possible,” Sandra Horning, M.D., chief medical officer and head of Genentech’s global product development, said in a press 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.”