"We are working to ensure that people with government-funded insurance, like Medicare or Medicaid, will have access to RELYVRIO as quickly as possible," Amylyx said in a statement to CNBC Make It. After Relyvrio's approval, Amylyx, the drug's manufacturer, announced that it would cost $158,000 a year. Yet, another potential issue to consider is access to the drug itself.
#Ice buckets trial#
Until the trial is completed, she plans to only recommend Relyvrio as a combination therapy, in conjunction with pre-existing medications. "Across the board, everybody wants a bigger trial, and everybody wants more evidence," she says, "But I think at the end of the day we can all agree, too, that a majority of ALS patients do not have that time."Īnother trial with more participants is in the works to further test the drug's efficiency, and Young is hopeful that it will provide more assurance. "Given the serious and life-threatening nature of ALS and the substantial unmet need, this level of uncertainty is acceptable in this instance," the agency wrote in its benefit-risk assessment.Īnd while Young would've preferred that the trial had more participants, she does agree with the FDA's decision. Normally, for a drug to become FDA-approved, two smaller independent studies, with less than 1,000 patients, showing similar results or one large study with positive results across the board are required. "There's just a general concern out there that maybe the trial is wrong," David Rind, chief medical officer for the Institute for Clinical and Economic Review, told NPR.įor experts like Rind, some of the hesitancy can be attributed to the fact that FDA approval of Relyvrio was made after just one study of only 137 patients. But while people living with ALS are excited and hopeful about the drug's approval, some experts are nervous that it was greenlit too soon and without enough scrutiny.
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