FDA Approves Biogen Idec Pill for Multiple Sclerosis
The Food and Drug Administration announced Wednesday it approved a new drug from Biogen Idec to control multiple sclerosis in adults, according to a statement. It is widely expected to become the No. 1 oral treatment for the disease, with annual sales topping $3 billion.
The drug, Tecfidera, activates a chemical pathway in the body known as Nrf2 that helps protect nerve cells from damage and inflammation. Following Wednesday's approval by the Food and Drug Administration, Biogen said it will launch the drug within the coming days.
"No drug provides a cure for multiple sclerosis, so it is important to have a variety of treatment options available for patients," said Russell Katz, MD, director of the Division of Neurology Products in the FDA's Center for Drug Evaluation and Research, in a statement.
The drug acts by reducing lymphocytes, which can raise the risk for infection, so the FDA is recommending monitoring before the start of treatment and then annually thereafter, the statement notes.
"We expect a solid launch of Tecfidera, and our sense is that there is a bolus of patients in the queue ready to transition to therapy," Geoff Meacham, an analyst at J.P. Morgan, said in a research note. "However, we believe that Street expectations likely already account for this and then some."
Multiple sclerosis is a chronic condition that attacks the central nervous system and can lead to numbness, weakness, paralysis and blindness. It affects more than 2.1 million people worldwide, according to the National Multiple Sclerosis Society.