Europe lines up first CRISPR therapy approval

Fol­low­ing FDA ap­proval, Ver­tex Phar­ma­ceu­ti­cals and CRISPR Ther­a­peu­tics on Fri­day re­ceived a pos­i­tive rec­om­men­da­tion for a con­di­tion­al ap­proval by a key Eu­ro­pean med­i­cines pan­el for the two com­pa­nies’ Cas­gevy, the first treat­ment that us­es CRISPR-based gene edit­ing tech­nol­o­gy.

The EMA’s Com­mit­tee for Med­i­c­i­nal Prod­ucts for Hu­man Use rec­om­mend­ed that Cas­gevy re­ceive a con­di­tion­al ap­proval dur­ing its De­cem­ber meet­ing held Mon­day through Thurs­day. The rec­om­men­da­tion comes af­ter Cas­gevy won FDA ap­proval last week, mark­ing a ma­jor mile­stone in treat­ing sick­le cell dis­ease.

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