Paul Perreault, CSL Behring CEO

CSL lands FDA ap­proval for he­mo­phil­ia B gene ther­a­py, sets $3.5M list price

The FDA has ap­proved the world’s first gene ther­a­py for he­mo­phil­ia B, ush­er­ing in­to the mar­ket a treat­ment that’s his­toric in both what it promis­es to do and how much it will cost.

CSL will be mar­ket­ing the drug, Hem­genix, at a list price of $3.5 mil­lion — which sets a new record for the most ex­pen­sive sin­gle-use gene ther­a­py in the US.

In a state­ment pro­vid­ed to End­points News, the Aus­tralian com­pa­ny not­ed that the cur­rent costs of treat­ing peo­ple with mod­er­ate to se­vere he­mo­phil­ia B can be sig­nif­i­cant over a life­time. By some es­ti­mates, health­care sys­tems could spend more than $20 mil­lion per per­son.

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