The US Food and Drug Administration (FDA) has approved the ACTPen for Genentech’s Actemra, a single-dose, prefilled autoinjector to treat rheumatoid arthritis (RA), giant cell arteritis and two forms of juvenile arthritis.
The US regulator ACTPen 62 mg/0.9 mL as an additional formulation for adult patients with moderate to severe active RA who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs (DMARDs) and adult patients with giant cell arteritis (GCA).
The caregivers can use ACTPen for patients two years of age and older with active polyarticular juvenile idiopathic arthritis (PJIA) or active systemic juvenile idiopathic arthritis (SJIA).
Genentech intends to make ACTPen available to customers in January 2019.
Roche chief medical officer and global product development head Dr Sandra Horning said: “When it comes to the administration of medicines, we believe patients should have choices, when possible.
“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 ACTPen was approved based on clinical data from two studies. The first study is an open-label, randomized, two-period and crossover phase I study designed to assess the relative bioavailability of a single injection of Actemra 162mg SC through the PFS with needle safety device to a single injection of Actemra 162 mg SC via the ACTPen in 188 healthy volunteers.
The second trial is an open-label, non-randomized and observational Phase IV human factors study in 54 adult RA patients designed to assess whether the ACTPen could be used safely and effectively by patients, caregivers or health care professionals to administer the Actemra injection.
According to the company, the studies show that the single-dose SC administration of 162 mg Actemra with the ACTPen was bioequivalent to administration with the currently marketed PFS.
Actemra was the first humanized interleukin-6 (IL-6) receptor antagonist secured approval to treatadult patients with moderately to severely active RA who have used one or more DMARDs uch as methotrexate (MTX).
In January 2010, the FDA first approved Actemra intravenous infusion formulation (IV) for adults with RA. In October 2013, the Actemra pre-filled syringe (PFS) formulations for subcutaneous injection (SC) for adults with RA were also approved.