EMA signs off on 3 drugs re­cent­ly re­ject­ed by FDA, in­clud­ing Bio­Mar­in's new he­mo­phil­ia gene ther­a­py

The EMA’s hu­man med­i­cines com­mit­tee on Fri­day rec­om­mend­ed three new drugs for ap­proval or con­di­tion­al ap­proval, even as their US coun­ter­parts have re­ject­ed these three for var­i­ous rea­sons.

In a ma­jor move, CHMP of­fered a thumbs-up to a con­di­tion­al mar­ket­ing au­tho­riza­tion for the first gene ther­a­py to treat se­vere he­mo­phil­ia A, al­though the agency cau­tioned that it’s so far un­known how long the ef­fects of in­fu­sion will last.

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