Avro­bio re­tools Fab­ry gene ther­a­py plans af­ter com­pet­ing drug's full ap­proval shuts path­way to an ac­cel­er­at­ed nod

It’s been a long road for lentivi­ral gene ther­a­py play­er Avro­bio in the rare lyso­so­mal dis­or­der Fab­ry dis­ease af­ter ear­ly da­ta sent in­vestors run­ning for the hills back in 2018. Right on the heels of a promis­ing read­out, Avro­bio will now tin­ker with its reg­u­la­to­ry plans for that ther­a­py af­ter the FDA flipped the script and hand­ed a com­pet­ing drug an un­like­ly full ap­proval.

The biotech will re­jig­ger its de­vel­op­ment plans for AVR-RD-01, an in­ves­ti­ga­tion­al gene ther­a­py for Fab­ry dis­ease, af­ter the FDA grant­ed a full ap­proval to Sanofi’s en­zyme re­place­ment ther­a­py Fab­razyme back in March, val­i­dat­ing a new kid­ney biop­sy sur­ro­gate end­point Avro­bio now hopes to pur­sue, the com­pa­ny said Mon­day.

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