Bio­Marin nets con­di­tion­al ap­proval for val­rox in Eu­rope, mark­ing the first he­mo­phil­ia gene ther­a­py

As Bio­Marin pre­pares to head back to the FDA with its he­mo­phil­ia A gene ther­a­py, the EU is sail­ing for­ward at full speed ahead.

The Eu­ro­pean Com­mis­sion grant­ed con­di­tion­al ap­proval to the com­pa­ny’s val­oc­toco­gene rox­a­parvovec — more col­lo­qui­al­ly known as val­rox — Wednes­day af­ter­noon, mak­ing it the first he­mo­phil­ia A gene ther­a­py ap­proved any­where. Val­rox, to be brand­ed on the con­ti­nent as Roc­ta­vian, will treat adults with se­vere he­mo­phil­ia A who need reg­u­lar treat­ments to pre­vent bleed­ing episodes.

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