One hur­dle down? FDA won't hold ad­comm for Bio­Mar­in's he­mo­phil­ia gene ther­a­py af­ter all

The FDA may be tak­ing its time re­view­ing Bio­Marin’s gene ther­a­py for he­mo­phil­ia A, but at least the biotech now has one few­er thing to wor­ry about.

While the agency has pre­vi­ous­ly planned to con­vene an ex­ter­nal pan­el of ad­vi­sors to weigh in on the pro­gram, com­mon­ly re­ferred to as val­rox (or by its brand name, Roc­ta­vian), Bio­Marin said it was re­cent­ly told that there won’t be an ad­comm af­ter all.

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