Biogen submits new MS drug for FDA approval
Specialty drugmaker Biogen Idec said Tuesday it submitted a new injectable multiple sclerosis drug to the Food and Drug Administration for U.S. market approval.
The drug, called Plegridy, is intended to treat patients with relapsing forms of multiple sclerosis, a disease of the immune system in which the body attacks the brain and spinal cord. Multiple sclerosis can be difficult to treat because symptoms can come and go, often reappearing months later.
Biogen's application includes the first year of data from a two-year study of the drug. The company also plans to submit the drug to the European Medicines Agency in coming weeks
Biogen also markets the multiple sclerosis drugs Avonex and Tysabri, the latter under an agreement with Elan Pharmaceuticals Inc.