The twice-a-day capsules, called Tecfidera, offer a new option for multiple sclerosis, a debilitating disease in which the body attacks its own nervous system. US-based Biogen Idec already sells two other drugs for the disease, but both require injections.
There is no cure for multiple sclerosis and most patients experience relapses of symptoms, including loss of balance, weakness in arms and legs and blurred vision. Over time patients usually become weaker and less coordinated. More than 2 million people worldwide have the disease, according to the Multiple Sclerosis International Federation.
Why the FDA approved the medication
The FDA said it approved Tecfidera based on two studies showing patients taking the drug had fewer relapses than patients taking a dummy pill.
The approval gives Biogen a new product in an increasingly crowded field of multiple sclerosis drugs.
The biotech drugmaker already sells the once-a-week multiple sclerosis injection Avonex. It also markets the once-a-month injection Tysabri through a partnership with Elan Corp. PLC of Ireland. However, Tysabri's severe side effects have curtailed its use.
Tecfidera is designed to be taken orally, which could make it a preferred option for patients and doctors. Novartis launched the first pill-based multiple sclerosis drug, Gilenya, in March 2011.
Top selling drug for the disease
The top-selling drug for the disease worldwide is Copaxone, which is made by Teva Pharmaceutical Industries. That injection had sales of nearly R36 billion last year, according to Teva's latest financial report.
Avonex and Tysabri had annual sales of R24 billion and R14 billion in 2011, the most recent year for which Biogen has reported annual sales.
A company representative could not immediately provide details on Tecfidera's pricing.
Biogen Idec Inc. shares rose R51.70, or 3.2%, to close Wednesday at R1,689.