Roche adds a stel­lar round of piv­otal da­ta on Hem­li­bra, look­ing to ex­pand its mar­ket for a po­ten­tial mega-block­buster

Roche just rolled out a slate of new da­ta that once again show why Hem­li­bra has roiled the fu­ture of one of Shire’s big ther­a­peu­tic fran­chis­es.

In­ves­ti­ga­tors have col­lect­ed new late-stage da­ta on the drug demon­strat­ing a dra­mat­ic re­duc­tion in bleed­ing for a swath of he­mo­phil­ia pa­tients, amp­ing up an­a­lysts’ ex­pec­ta­tions for the drug to be­come the next stan­dard of care in he­mo­phil­ia.

The da­ta came from two sep­a­rate Phase III tri­als that are in­tend­ed to eval­u­ate the drug in non-in­hibitor pa­tients — those who haven’t de­vel­oped re­sis­tance to fac­tor re­place­ment ther­a­py — and on a month­ly dos­ing sched­ule, re­spec­tive­ly. In HAVEN 3, when com­pared to pa­tients who re­ceived no pro­phy­lax­is, those who got Hem­li­bra every week or every two weeks showed a 96% and 97% re­duc­tion in treat­ed bleeds (p<0.0001 for both fig­ures). And through an in­tra-pa­tient com­par­i­son among a sub­set of pa­tients who pre­vi­ous­ly re­ceived fac­tor VI­II pro­phy­lax­is, Roche not­ed a 68% re­duc­tion ((p<0.0001) in treat­ment bleeds.

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