Sanofi earns break­through nod in he­mo­phil­ia A as it con­tin­ues to play catch-up with Roche's Hem­li­bra

As Sanofi pre­pares to present its he­mo­phil­ia A pitch to the FDA, reg­u­la­tors are ac­knowl­edg­ing the po­ten­tial of the Big Phar­ma’s ex­per­i­men­tal drug.

The agency grant­ed break­through ther­a­py des­ig­na­tion to Sanofi’s fac­tor VI­II re­place­ment ther­a­py efane­soc­tocog al­fa ear­ly Wednes­day morn­ing, rough­ly three months af­ter the pro­gram read out pos­i­tive Phase III da­ta. It’s a boost for Sanofi and part­ner So­bi, who are try­ing to beat sev­er­al gene ther­a­pies to mar­ket and take on Roche’s Hem­li­bra, among oth­er promi­nent drugs from Bay­er, Take­da and No­vo Nordisk.

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