ARTICLE | Company News

GSK refocusing autoimmune program for ofatumumab

September 17, 2010 12:32 AM UTC

GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) and Genmab A/S (CSE:GEN) said GSK will discontinue further development of IV ofatumumab for autoimmune indications, including rheumatoid arthritis (RA), for which the IV formulation was in Phase III testing. GSK will focus instead on development of a subcutaneous formulation, which the companies said has the potential to offer added convenience and improved tolerability. The pharma plans to begin a Phase IIb trial next year to evaluate subcutaneous ofatumumab to treat multiple sclerosis (MS). GSK is responsible for all development of ofatumumab for autoimmune indications under an amended 2006 deal. The partners will continue to develop the IV formulation for cancer indications. The IV formulation of the drug has conditional approval in the EU to treat chronic lymphocytic leukemia (CLL) refractory to fludarabine and alemtuzumab, as well as accelerated approval in the U.S. for the indication. ...