On Wednesday, the US Food and Drug Administration approved the multiple sclerosis pill Aubagio from drugmaker Genzyme, a subsidiary of Sanofi Aventis, which is used to treat adults with relapsing forms of the chronic disease.
Aubagio (teriflunomide) is only the second oral pill for multiple sclerosis treatment available in the US market. Gilenya, from Novartis AG, became the first oral pill available in the US in 2010. According to the Wall Street Journal, world-wide sales of Gilenya surpassed $530 million in the first half of this year.
“In a clinical trial, the relapse rate for patients using Aubagio was about 30 percent lower than the rate for those taking a placebo,” said Russell Katz, director of the Division of Neurology Products at the FDA. “Multiple sclerosis can impair movement, sensation, and thinking, so it is important to have a variety of treatment options available to patients.”
Health officials say that multiple sclerosis affects around 2.5 million people worldwide. The disease — which attacks the central nervous system, crippling nerves controlling muscles and vision which can lead to paralysis and vision loss — has no cure.
Although Aubagio is said to have milder side-effects compared to its rival, the multiple sclerosis pill was approved with the strictest FDA boxed warning. The FDA says that women of child-bearing age will need to have a negative pregnancy test before starting the pill, as it can potentially cause birth defects. Additionally, the FDA warns that liver problems may develop and that doctors should run liver function tests on patients before prescribing Aubagio.