FDA has approved ACTPen 162 mg/0.9 mL,autoinjector for Actemra. Genentech/Roche.
Genentech, a member of the Roche Group announced that the 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. ACTPen is expected to be available in January 2019.
The approval of the ACTPen is based on clinical data from two studies that were presented at the 2018 American Society for Clinical Pharmacology & Therapeutics Annual Meeting. The first was an open-label, randomized, two-period, crossover Phase I study, investigating the relative bioavailability of a single injection of Actemra 162 mg SC via the PFS with needle safety device to a single injection of Actemra 162 mg SC via the ACTPen in 188 healthy volunteers. The second was an open-label, non-randomized, observational Phase IV human factors study in 54 adult RA patients investigating whether the ACTPen could be used safely and effectively by patients, caregivers or health care professionals to administer the Actemra injection. The studies found that the single-dose SC administration of 162 mg Actemra with the ACTPen was bioequivalent to administration with the currently marketed PFS, and the intended users of the ACTPen were successful in performing the tasks required to administer doses of Actemra. The adverse events of Actemra in both studies were consistent with the medicine's established safety profile.
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