FDA Grants Breakthrough Therapy Designation for Actemra (tocilizumab) in Systemic Sclerosis

Author: Genentech
Date Published: June-2015
Source: Genentech

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation status to Actemra® (tocilizumab) for systemic sclerosis, also known as scleroderma.1 This designation is intended to expedite the development and review of medicines with early signals of potential clinical benefit in serious diseases and to help ensure patients have access to them as soon as possible. Genentech has also initiated a Phase III study in systemic sclerosis (NCT02453256), a disease for which there are inadequate treatment options.3,4