New Autoinjector Formulation for Tocilizumab Granted FDA Approval

Officials with the FDA have approved Genentech’s single-dose, prefilled autoinjector ACTPen 162 mg/0.9 mL for tocilizumab (Actemra) for patients with rheumatoid arthritis (RA), giant cell arteritis (GCA), and 2 forms of juvenile arthritis, according to a press release.

The additional formulation is indicated for adult patients with moderate-to-severe RA who have had an inadequate response to 1 or more disease-modifying antirheumatic drugs (DMARDs) and for adults with GCA. The ACTPen can also be administered by caregivers to patients 2 years of age and older with active polyarticular juvenile idiopathic arthritis (PJIA) or active systemic juvenile idiopathic arthritis (SJIA), Genentech stated.

ACTPen’s approval is based on data from 2 clinical trials. The first study investigated the relative bioavailability of a single injection of tocilizumab 162 mg subcutaneous (SC) via the pre-filled syringe (PFS) with needle safety device to a single injection of tocilizumab 126 mg SC via the ACTPen in 188 healthy volunteers.

The second study, which included 54 adult patients with RA, evaluated the safety and efficacy of ACTPen for administering tocilizumab injection. According to the data, the single-dose SC administration of 162 mg tocilizumab with ACTPen was bioequivalent to administration with the currently marketed PFS. Additionally, the intended users of the ACTPen were successful in performing the tasks required to administer doses of tocilizumab, according to the study.

The clinical data from these 2 studies were presented at the 2018 American Society for Clinical Pharmacology and Therapeutics Annual Meeting.

“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, said in a statement. “With ACTPen for Actemra, we are pleased to offer an additional option to patients who may prefer using the new autoinjector over other formulations.”

According to Genentech, the ability of pediatric patients to self-inject with ACTPen has not been tested. ACTPen is anticipated to be available in January 2019, the release stated.

Reference

FDA Approves The ACTpen For Genentech’s ACTEMRA, A Single-Dose, Prefilled Autoinjector For The Treatment Of Rheumatoid Arthritis, Giant Cell Arteritis And Two Forms Of Juvenile Arthritis [news release]. Genentech’s website. https://www.gene.com/media/press-releases/14767/2018-11-26/fda-approves-the-actpen-for-genentechs-a. Accessed November 26, 2018.