Genentech's ACTpen Receives FDA's Approval for Actemra (tocilizumab) to Treat Rheumatoid Arthritis (RA)- Giant Cell Arteritis (GCA) and Two Forms of Juvenile Arthritis
Shots:
- 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
Ref: Genentech | Image: HuffPost
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