GlaxoSmithKline and Genmab's rheumatoid arthritis drug Arzerra (ofatumumab) performed well in a Phase III trial in patients who had not responded to the common RA drug methotrexate. After 24 weeks, subjects reported a 20 percent or greater improvement in the number of swollen and tender joints, as well as improvements in other disease-activity measures--the primary endpoint of the trial. One patient died during the study, but an investigator ruled the death unrelated to the drug.
In May, Arzerra was backed by an FDA panel for the treatment of chronic lymphocytic leukemia, but the drug's full FDA approval was delayed as the agency asked for more time to review the drug's chemistry and manufacturing data. Approval for the leukemia indication is expected at the end of October.
- here's the release
- read the Reuters article for more