FDA clears Roche's Actemra/RoActemra

The Food and Drug Administration has approved Roche’s Actemra/RoActemra (tocilizumab) subcutaneous injection for slowing the rate of decline in pulmonary function in adult patients with systemic sclerosis-associated interstitial lung disease, or SSc-ILD, a debilitating condition with limited treatment options. Actemra/RoActemra is the first biologic therapy approved by the FDA for the treatment of the disease.

SSc, also known as scleroderma, is an often devastating autoimmune disease that worsens over time and has no cure. It occurs when the immune system malfunctions causing tissues of the skin and lungs to thicken and harden. SSc affects about 2.5 million people worldwide.

Interstitial lung disease, which may occur in approximately 80% of SSc patients, causes inflammation and scarring of the lungs and can be life-threatening.

“We are honored to offer the very first FDA-approved biologic treatment option to people living with systemic sclerosis-associated interstitial lung disease,” said Levi Garraway, Roche's chief medical officer and head of Global Product Development. “We worked closely with the FDA to evaluate Actemra/RoActemra’s impact on lung function in this setting. This milestone approval provides a much-needed new treatment option for people living with this rare, debilitating disease.”