FDA Provides Breakthrough Therapy Status for Roche Drug
Roche reports that the US Food and Drug Administration (FDA) has granted breakthrough therapy designation status to Acterma/RoActerma (tocilizumab) for systemic sclerosis (SSc). Roche also initiated a global Phase III study in SSc.
Acterma/RoActerma is an anti-IL-6 receptor biologic approved in intravenous (IV) and subcutaneous formulations, for the treatment of adult patients with moderate-to-severe active rheumatoid arthritis (RA). The IV formulation is approved in most major countries for polyarticular juvenile idiopathic arthritis or systemic juvenile idiopathic arthritis in children two years of age and older. In Europe, the drug is also approved for use in patients with severe, active and progressive RA. The drug is is part of a co-development agreement with Chugai Pharmaceutical Co., Ltd and has been approved in Japan since April 2005 and in more than 100 countries overall.