The Food and Drug Administration has approved a drug developed by Regeneron Pharmaceuticals of Tarrytown and the French drug maker Sanofi designed to treat colorectal cancer that has metastasized.
Zaltrap was approved for use in patients whose disease has not responded to initial treatment. It was approved following a priority review by the FDA, a designation given to drugs that offer major advances in treatment or provide treatment where there had previously been none. Marketing applications for Zaltrap are being reviewed by regulatory agencies in Europe and elsewhere around the world.
Sanofi plans to make the drug available in the U.S. in the third quarter of this year. Sanofi and Regeneron will share equally in the profits of Zaltrap after Regeneron”™s agreement to repay its share of development expenses.
Meanwhile, the FDA said it needed more information before deciding whether to approve another Regeneron drug, Arcalyst, for the treatment of gout.
