FDA approves use of Actemra/RoActemra in interstitial lung disease

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

Roche’s (ROG: SIX) Actemra/RoActemra is the first biologic therapy approved by the FDA for the treatment of the disease, the Swiss pharma giant noted. Mainly used in the treatment of rheumatoid arthritis (RA), Actemra/RoActemra pulled in global sales of 2.9 billion Swiss francs ($3.2 billion) in full-year 2020, a rise of 32%.

Systemic sclerosis (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 (ILD), which may occur in around 80% of SSc patients, causes inflammation and scarring of the lungs and can be life-threatening.

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