Roche Holding AG’s Actemra (tocilizumab) has received its latest in a string of US Food and Drug Administration approvals, for interstitial lung disease associated with systemic sclerosis (SSc-ILD), after the company managed to drill down and find a suitable subgroup out of two trials in SSc that failed overall. The approval comes at a time when Actemra is projected to see gradual sales declines and biosimilar competition over the next few years.
Roche said 5 March that it had received an FDA nod for Actemra as the first approved drug for slowing decline in pulmonary function in adults with SSc-ILD, based on secondary endpoint data from two late-stage clinical trials. A rare autoimmune disease also known as scleroderma, SSc affects about 2
