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.

Unlock this article instantly by becoming a free subscriber.

You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.