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Roche: FDA Approves Actemra/RoActemra For Systemic Sclerosis-associated Interstitial Lung Disease

Roche (RHHBY) said FDA has approved Actemra/RoActemra subcutaneous injection for slowing the rate of decline in pulmonary function in adult patients with systemic sclerosis-associated interstitial lung disease. Actemra/RoActemra is the first biologic therapy approved for the treatment of the disease. The FDA approval is based on data from the focuSSced trial, a phase III randomised, double-blind, placebo-controlled clinical trial.

The company noted that this is the sixth FDA approved indication for Actemra/RoActemra since the medicine was launched in the U.S. in 2010.

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