Roche announced positive results from a late-stage trial of Actemra for systemic onset Juvenile Idiopathic Arthritis (sJIA), a disease that causes intermittent fever, rash, and arthritis symptoms. The drug--a potential blockbuster--met its primary endpoint by significantly improving disease signs and symptoms. Patients treated with the Actemra experienced a significant reduction in the signs and symptoms of the disease after 12 weeks of treatment compared with those in the placebo arm. Additionally, the drug was generally well tolerated.
Actemra is one of the Swiss drugmaker's greatest pipeline hopes, and has been approved by Japanese and European regulators. Despite winning backing from an expert panel, Roche was dealt a serious setback last year when the FDA declined to approve the drug for the treatment of rheumatoid arthritis, delaying it for at least 18 months. The company said full data and safety follow-up from this trial will be used to support future regulatory filings for a label in a sJIA indication. If approved, Actemra would be the first drug available to treat sJIA.
- check out Roche's release
- read the report from Reuters