FDA approves new oral MS drug, Tecfidera

U.S. regulators on Wednesday approved a new multiple sclerosis drug made by Biogen Idec Inc that 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.

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.

"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."

Shares of Weston, Massachusetts-based Biogen rose 3.2 percent to close at $182.68 on Wednesday. The shares have more than tripled over the past three years, mainly driven by high hopes for Tecfidera, known chemically as dimethyl fumarate.

Biogen already sells the MS drugs Avonex and Tysabri, which together account for about 30 percent of the market. Teva Pharmaceutical Industries Ltd's drug Copaxone is the current market leader, with a roughly 29 percent share and annual sales last year of more than $4 billion.

Unlike Copaxone, Avonex and Tysabri, which are injected or infused, Tecfidera comes in the more convenient form of a pill. As such, it will compete with Novartis AG's MS pill Gilenya, which, though first to market, has been dogged by heart safety concerns. Gilenya holds an 8.5 percent share of the market and generated worldwide sales of $1.2 billion last year.

Tecfidera will also compete with Sanofi's recently approved MS pill Aubagio. Aubagio's label carries a boxed warning -- the most serious kind of warning -- alerting physicians to a potentially heightened risk of liver problems.

Novartis said in a statement that it welcomed additional treatment options for people with MS, but warned that Tecfidera may not perform as well in the market as in clinical trials.

"As with any new medication, real-world experience is critical to gain an accurate understanding of a therapy's full clinical profile," the company said. "It will be important to see the clinical profile of dimethyl fumarate -- including efficacy, safety, tolerability and adherence with its twice-a-day dosing -- as it gains real-world experience."

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FDA approves new oral MS drug, Tecfidera