Tecfidera, a new drug, has been given approval by the U.S. Food and Drug Administration to treat adult patients that have relapsing forms of the disease multiple sclerosis. The U.S. regulatory agency’s approval was based upon results of two trials that showed patients taking Tecfidera capsules had fewer relapses of MS than those who only received inactive placebos.
One of the two clinical trials also indicated that a MS-related disability that was worsening, occurred less in patients who were taking the new drug than in those patients who only were taking a placebo.
A director of a multiple sclerosis center in New York said the new drug would be a good addition to the increasing list of medications that alter the disease’s course. The new agent said the director, based on the data from the clinical trial, has quite impressive efficacy data and a sound safety profile.
Tecfidera, said the FDA, might lower white blood cell levels, which help protect from infection. Lower white blood cell levels in the body increase the risk of an infection, but no substantial increase of infections was noted in the patients taking Tecfidera.
Prior to starting the treatment using Tecfidera and each year thereafter, doctors should review the white blood cell counts of their patients, advised the FDA.
Side effects of the drug included nausea, vomiting, flushing, and diarrhea, especially when the treatment using the drug started. Biogen Idec based in Massachusetts develops the drug.
MS is a central nervous system autoimmune disease. It disrupts the flow of communication between the brain and parts of the body, which results in different problems such as difficulty with balance, coordination and muscle weakness.