Actemra designated Breakthrough Therapy after 'meaningful' PhII results

10 June 2015

The US Food and Drug Administration has granted breakthrough therapy designation to Actemra/RoActemra (tocilizumab) from Swiss pharma major Roche (SIX: ROG) for systemic sclerosis (SSc).

SSc is a rare, chronic disorder characterized by blood vessel abnormalities, as well as degenerative changes and scarring in the skin, joints, and internal organs. It is estimated to affect approximately 2.5 million people worldwide, and has the highest mortality of any rheumatic disease.

Based on Phase II results

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