FDA clears subcutaneous formulation of Actemra for PJIA

Jun 25, 2018, 9:50am



The subcutaneous formulation of Actemra (tocilizumab, Genentech) has been approved by the Food and Drug Administration (FDA) for the treatment of polyarticular juvenile idiopathic arthritis (PJIA) in patients ages 2 years and older, according to a recent news release.

“With this approval, we are pleased Actemra offers an alternative delivery option to physicians and parents of children ages 2 or older to treat this debilitating disease,” Sandra Horning, M.D., chief medical officer and head of Global Product Development, Genentech, said in the news release.

For patients with PJIA, physicians can prescribe the subcutaneous formulation of Actemra alone or in conjunction with methotrexate. An intravenous formulation of Actemra was approved by the FDA in 2013 for patients with PJIA ages 2 years and up.

The FDA approval follows results of the JIGSAW-117 study, which was designed to assess the appropriate dosing of subcutaneous Actemra in a range of body weights for juvenile patients. The 52-week, open-label, multicenter, phase 1B pharmacokinetic (PK) and pharmacodynamic (PD) bridging study involved 52 patients with PJIA, ages 1 to 17 years. The patients demonstrated previous inadequate response or an intolerance to methotrexate treatment and were Actemra naïve or had received intravenous Actemra with adequate disease control.

Patients weighing 30 kg or more received 162 mg of Actemra every two weeks for a year. Patients weighing less than 30 kg were given 162 mg of Actemra every three weeks.

“The efficacy of Actemra SC in children 2 to 17 years of age is based on PK exposure and extrapolation of established efficacy of Actemra IV in PJIA patients and Actemra SC in patients with RA,” the company stated.



*Original source: https://www.gene.com/media/press-releases/14718/2018-05-14/fda-approves-subcutaneous-formulation-of