Roche single-dose prefilled autoinjector ACTPen approved

2024-06-17 02:05:45

Roche single-dose prefilled autoinjector ACTPen approved

November 27, 2018 Source: Bio Valley

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Swiss pharmaceutical giant Roche recently announced that the US Food and Drug Administration (FDA) has approved ACTPen (162mg/0.9mL), a single-dose prefill for the anti-inflammatory drug Actemra (tocilizumab, tocilizumab). Autoinjector for: (1) treatment of adult patients with moderate to severe active rheumatoid arthritis (RA) who are not responding to one or more disease-modifying antirheumatic drugs (0DMARDs); (2) For the treatment of adult patients with giant cell arteritis (GCA); (3) for use by nursing staff for active polyarticular juvenile idiopathic arthritis (pJIA) and active systemic juvenile idiopathic age 2 years and older Treatment of patients with arthritis (sJIA).

Currently, the ability of pediatric patients to use ACTPen for self-injection has not been tested. Roche has planned to bring ACTPen to market in January 2019, which will provide additional treatment options for patients who prefer to use auto-injectors instead of other preparations such as intravenous infusion.

Actemra is the first monoclonal antibody to humanized interleukin-6 (IL-6) receptor antagonist that can be administered by intravenous infusion (IV) and subcutaneous (SC). Symptoms, including: rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (pJIA), systemic juvenile idiopathic arthritis (sJIA), giant cell arteritis (GCA), cytokine release synthesis Signs (CRS), Castleman's disease, arteritis.

Actemra includes IV formulations and SC prefilled syringe (PFS) formulations that vary in specific indications in different countries and regions. Since its launch in 2010, more than 1 million patients worldwide have received Actemra treatment.

The approval of ACTPen is based on data from two clinical studies. The first study was an open-label, randomized, two-phase, crossover Phase I study conducted in 188 healthy volunteers who evaluated a single injection of Actemra 162 mg SC with a needle-safe device PFS versus a single injection via ACTPen. Bioavailability of Actemra 162mg SC. The second study, an open-label, non-randomized, observational phase IV human factor study conducted in 54 adult patients with rheumatoid arthritis, investigated whether ACTPen can be safely and effectively used by patients, caregivers, or health care professionals. For the administration of Actemra injection.

The study found that 162 mg of Actemra administered with ACTPen single dose SC was bioequivalent to PFS administration of current sales, and users of ACTPen successfully performed the task of administering the required dose of Actemra. In both studies, Actemra's adverse events were consistent with the established safety profile of the drug.

Original Source: FDA approves the ACTPen for Roche's Actemra, a single-dose, prefilled autoinjector for the treatment of rheumatoid arthritis, giant cell arteritis and two forms of juvenile arthritis

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