New Pill May Reduce Relapses in MS Patients
Study Shows Teriflunomide Could Become a New Alternative to Injections
Testing a New Pill to Control MS continued...
There were three cases of serious kidney infections in people taking the higher drug dose. One led a person to quit the study.
Because the drug interferes with fast-growing cells, researchers say women who are pregnant or planning a pregnancy should not take the medication.
Anita Burrell, a vice president at Sanofi-Aventis, the drug's manufacturer, says the company has applied to the FDA for review. They should know this month if the agency has accepted their application.
"We know cost is a big issue in the MS environment. But it's clearly too premature at this point to speculate for this product in particular," she says.
MS drugs are some of the most expensive therapies on the market. A study published earlier this year in Neurology found that the health gains MS patients get from their medications come at extremely high prices.
Gilenya, the pill that's already available to patients, costs $4,000 a month, or $48,000 annually. By comparison, the injectable drug Copaxone costs between $2,800 and $3,200 a month.
Experts who were not involved in the study say they think there's a good chance it will be approved by the FDA.
"It's my opinion that this drug needs to be on the market," says Jack Burks, MD, a neurologist in Reno, Nev., and chief medical officer of the Multiple Sclerosis Association of America. "People should be given the opportunity to take this drug. Whether they take it or not should be up to the patient and the doctor."
He says teriflunomide appears to be effective and safe, at least in the short term.
"We don't know the long-term safety. Therefore we're cautiously optimistic that the long-term safety data will be good and people who don't want to take shots anymore won't have to," Burks says.
"Just because it's a pill doesn't mean it's safer," he says.