FDA approves Genentech’s ACTPen for giant cell arteritis

Genentech has landed FDA approval for a single-dose autoinjector filled with tocilizumab (Actemra) for patients with giant cell arteritis (GCA). The device, ACTPen 162 mg/0.9 mL, will likely become available in January 2019.

The approval stems from a pair of clinical studies presented at the 2018 American Society for Clinical Pharmacology & Therapeutics annual meeting. The studies found that subcutaneous administration of tocilizumab via the ACTPen was as effective as the currently marketed prefilled syringe, and that patients could successfully use the pen to deliver doses of tocilizumab. Adverse events were consistent with the drug’s established safety profile.

“When it comes to the administration of medicines, we believe patients should have choices, when possible,” said Sandra Horning, MD, chief medical officer and head of global product development. “With ACTPen for Actemra, we are pleased to offer an additional option to patients who may prefer using the new autoinjector over other formulations.”

About 30% of people with GCA develop visual problems and 15% experience permanent vision loss. Until recently, the condition was treated with prolonged periods of glucocorticoids. But that changed when phase 3 trials revealed that tocilizumab combined with a steroid taper outperformed a steroid-only regimen in patients with GCA, and more effectively sustained remission. The FDA approved the novel IL-6 receptor antagonist for GCA in 2017.

The ACTPen is also approved for the treatment of adults with refractory rheumatoid arthritis, and children 2 years of age and older with active polyarticular juvenile idiopathic arthritis or active systemic juvenile idiopathic arthritis.