Pfizer announced top-line results from the ORAL Scan phase III study of tofacitinib, formerly known as tasocitinib, an investigational, novel, oral JAK inhibitor. ORAL Scan is an ongoing two-year study in patients with moderate-to-severe active rheumatoid arthritis who had an inadequate response to methotrexate (MTX) and were randomized to receive tofacitinib 5 or 10 mg BID or placebo added to background MTX. No new safety signals emerged in the ORAL Scan study. The efficacy and safety profile of tofacitinib in this study remains consistent with that seen previously in the clinical program. A full analysis of the ORAL Scan efficacy and safety data will be submitted to a future scientific meeting.
Genentech announced that the FDA approved Actemra (tocilizumab) for the treatment of active systemic juvenile idiopathic arthritis (SJIA) in patients two years of age and older. SJIA is the rarest form of juvenile idiopathic arthritis.
Abbott Laboratories agreed to pay $52 million to resolve claims by direct drug buyers that it tried to harm competition when it quadrupled the price of its HIV medicine Norvir in 2003. The settlement, which is subject to court approval, would resolve a class-action lawsuit filed on behalf of Abbott customers that purchased Norvir, a boosting agent for other HIV drugs, and a second medicine Kaletra, which includes Norvir, according to an April 8 filing in federal court in Oakland, CA. Abbott denied wrongdoing, according to the accord.