Roche gets EU approval for RoActemra for children with rare form of arthritis

The European Commission has approved the use of Swiss drug major Roche’s (ROG: SIX) RoActemra (tocilizumab) for the treatment of active systemic juvenile idiopathic arthritis (sJIA) in patients two years of age and older who have responded inadequately to previous therapy with NSAIDs and systemic corticosteroids (medicines used to treat inflammation).

The drug, known as Actemra outside of Europe, is already used to treat adult rheumatoid arthritis in patients who were either intolerant to or failed to respond to other medicines to treat inflammation. In the first half of this year, sales of RoActemra/Actemra rocketed 99% to 277 million Swiss francs ($351.4 million). The drug is already approved for sJIA in the USA, Mexico, India and Switzerland, and Vontobel analyst Andrew Weiss is forecasting peak sales of around $2.6 billion a year.

“This approval in Europe is an important advance in the treatment of sJIA, a debilitating condition affecting children,” said Hal Barron, chief medical officer and head, global product development, adding: “RoActemra is the first and only biological treatment to demonstrate significant efficacy in this patient population and offers physicians a new option for this extremely difficult to treat disease.”