ZURICH (Reuters) - Swiss pharmaceuticals company Roche Holding AG said on Monday the European Medicines Agency has approved its rheumatoid arthritis drug RoActemra to treat children aged two or older suffering from a rare form of childhood arthritis.
RoActemra can be used to treat children who have not responded to treatment with methotrexate (MTX), an anti-rheumatic drug, either alone or in combination with MTX, Roche said.
In late April, EMA’s Committee for Medicinal Products for Human Use (CHMP) recommended approval for extended use of RoActemra, also known as Actemra outside of Europe.
Recommendations for marketing approval by CHMP are normally endorsed by the European Commission within a couple of months.
Reporting by Martin de Sa'Pinto; Editing by Daniel Magnowski