Novartis quietly used a PRV to speed the approval of its new rare blood disorder drug
The FDA disclosed on Friday that Novartis’ approval for its new $550,000 per year treatment for adults with paroxysmal nocturnal hemoglobinuria, or PNH, a rare disorder where the red blood cells break up early, came more quickly than usual thanks to the use of a material threat medical countermeasure (MCM) priority review voucher.
What’s unusual about the FDA’s announcement — and it reveals a lot about the opacity of the PRV program in general, where purchases can be made and go undisclosed — is that Novartis did not announce the use of a PRV when the Fabhalta approval came through last December.
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