A new MS drug earned FDA approval.
Novartis AG has won U.S. Food and Drug Administration approval for multiple sclerosis drug Mayzent as the Swiss company targets patients whose disease advances from intermittent attacks to a gradually worsening condition.
Novartis has priced the treatment at $88,000 annually, head of pharmaceuticals Paul Hudson told Reuters, a level exceeding some other MS drugs and one that may draw scrutiny from payers.
Mayzent was approved for adults with relapsing forms of the disease, including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease (SPMS), the FDA said. It said the drug’s benefits were not statistically significant in patients with non-active MS.
In a 1,651-person trial, 26 percent of patients who got Mayzent saw their disability progress after three months, less than the 32 percent of patients who got a placebo, amounting to a relative risk reduction of 21 percent.
The drug’s cost will likely attract attention, as the independent Boston-based group Institute for Clinical and Economic Review (ICER) has already suggested in a draft report that Mayzent, at the Novartis price, likely far exceeds levels generally thought to be cost-effective.
“We will find a way to bring it to market, so patients get the best clinical choice,” Hudson said. “I think we’ve been very responsible with the pricing of it.”
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