The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion for Arzerra, a treatment for chronic lymphocytic leukemia, which is a cancer of the blood and bone marrow. The CHMP has recommended the drug for patients whose disease continues to progress despite receiving fludarabine and alemtuzumab, the current standard of care.
Arzerra is also undergoing clinical trials for rheumatoid arthritis. It was also in testing for non-Hodgkin's lymphoma, but produced underwhelming results for that indication. The treatment was approved by U.S. regulators just a few months ago. GSK licensed the drug, also known as ofatumumab or HuMax CD-20, in 2007 for $2.1 billion.
- here's Genmab's release
- see the Dow Jones brief