FDA Approves ACTpen for Genentech’s ACTEMRA, a Single-Dose, Prefilled Autoinjector for Treatment of Rheumatoid Arthritis, Giant Cell Arteritis, & Two Forms of Juvenile Arthritis

On November 26,2018, Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), announced that the U.S. Food and Drug Administration (FDA) has approved ACTPen™ 162 mg/0.9 mL, a single-dose prefilled autoinjector for Actemra® (tocilizumab) as an additional formulation for adult patients with moderate to severe active rheumatoid arthritis (RA) who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs (DMARDs), and for adult patients with giant cell arteritis (GCA). Further, the ACTPen can be administered by caregivers to patients two years of age and older with active polyarticular juvenile idiopathic arthritis (PJIA) or active systemic juvenile idiopathic arthritis (SJIA). The ability of pediatric patients to self-inject with the ACTPen has not been tested. The ACTPen is expected to be available in January 2019. “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 for Roche/Genentech. “With ACTPen for Actemra, we are pleased to offer an additional option to patients who may prefer using the new autoinjector over other formulations.”The FDA first approved Actemra intravenous infusion formulation (IV) for adults with RA in January 2010 and Actemra pre-filled syringe (PFS) formulations for subcutaneous injection (SC) for adults with RA in October 2013. In May 2017, Actemra SC became the first therapy approved by the FDA for the treatment of adult patients with GCA, a chronic and severe form of vasculitis characterized by inflammation of certain large blood vessels.
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