- The approval is based on P-I & P-IV study assessing Actemra 162 mg SC via the pre-filled syringe (PFS) vs Actemra 162 mg SC via the ACTPen & testing safety and efficacy of ACTpen respectively
- The study demonstrated showing a single dose of Actemra 162 mg SC with ACTpen is bioequivalent to currently used PFS device, with no new safety signals observed.
- ACTpen (162 mg/0.9 mL) is a pre-filled auto-injector, for Actemra an interleukin-6 (IL-6) receptor antagonist, indicated to treat moderate-to-severe RA. It is expected to available for patients in Jan, 2019
Click here to read full press release/ article | Ref: Genentech | Image: HuffPost