FDA Approves New Oral Drug for Multiple SclerosisThe FDA has approved a new medication for people battling multiple sclerosis. The drug, Tecfidera, is expected to become the go-to treatment for the condition, according to Fox News.
Other treatments for multiple sclerosis are injected, or have serious side effects. Tecfidera is taken orally and, while it does have side effects, it doesn’t carry serious warnings like other drugs do.
“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.
Meacham and other medical analysts expect the drug to bring in big bucks.
“I expect the drug to meet consensus of $300 million this year, and over five years it can achieve greater than $3 billion in sales based on its convenience and efficacy profile,” Michael Yee, an analyst at RBC Capital Markets said.
Now offered to the public
According to the National Multiple Sclerosis Society, about 2.1 million people are affected by the condition. The disease, which affects the central nervous system, can cause paralysis.
The drug’s maker, Biogen, says clinical trials showed promise. Multiple sclerosis drugs are often judged by how well they quell relapses, experts told the NY Times. Clinical trials show Tecfidera cuts the relapse rate by up to 54 percent.
Now experts want to see what the drug can now that it is available by prescription.
“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.”