Roche submits application to FDA for Actemra
ZURICH, Switzerland Roche Holding AG has submitted a biologics license application with the Food and Drug Administration for approval of Actemra for the treatment of rheumatoid arthritis, according to money.cnn.com.
The drug aims to reduce the signs and symptoms in adults with moderate to severe rheumatoid arthritis. Actemra is the first humanised interleukin-6 receptor-inhibiting monoclonal antibody to treat rheumatoid arthritis filed for registration, according to Roche Holding.
“The filing for Actemra in the US is an important milestone for Roche, and brings us another step closer to making this therapy available to the millions of patients ... who suffer from the pain and debilitating effects of rheumatoid arthritis,” said William Burns, head of Roche’s pharma division.