Roche: FDA approves Actemra for rare pediatric disease
(CercleFinance.com) - The US Food and Drug Administration (FDA) has approved Roche's subcutaneous formulation of Actemra for the treatment of active polyarticular juvenile idiopathic arthritis in patients of two years and older, the Swiss drugmaker said on Tuesday.
Polyarticular juvenile idiopathic arthritis is a rare, often painful chronic disease that affects approximately 100 in every 100,000 children.
The approval is based on data from a 52-week study that enrolled 52 patients aged one to 17 years.
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