Regulatory Decision Summary for Actemra

Actemra for the treatment of Polyarticular Juvenile Idiopathic Arthritis (pJIA) was previously authorized for Intravenous (IV) administration. The subcutaneous (SC) dosage form was previously authorized for Rheumatoid Arthritis (RA) and Giant Cell Arteritis (GCA). This submission seeks market authorization for Actemra-SC and is expected to provide a more convenient dosing option than Actemra-IV for pJIA patients. The benefit of Actemra-SC administration in pJIA patients is supported by pharmacokinetic/pharmacodynamics-bridged efficacy extrapolation from Study WA28117 as well as comparable efficacy measures between SC (Study WA28117) and the authorized IV (Study WA19977) dose regimens. The safety data did not reveal new or unexpected adverse events associated with SC dosing compared to IV dosing. There are higher Injection site reactions associated with SC than IV, but this is not unexpected. There are some observed discrepancies in the safety profile (e.g. the incidence of decrease in neutrophil below 1 x 109 counts/L) between SC and IV dosing in pJIA, but this will be further addressed through the on-going long-term extension Study WA29231 and the post-marketing safety program.

Overall, the information presented in this SNDS suggest comparable efficacy and safety profiles between the proposed SC dose regimens, i.e., 162 mg once every 3 weeks for patients weighing < 30 kg and once every 2 weeks (Q2W) for patients weighing ≥ 30 kg, and the currently approved IV dose regimens for the same pJIA indication in patients 2 to 17 years of age. The risk-benefit assessment supports approval of Actemra-SC dose regimens as alternative to currently approved IV in patients with pJIA.