Roche gets pri­or­i­ty re­view for Hem­li­bra's sec­ond in­di­ca­tion; Ora­sis gets $13M B round for pres­by­opia eye drop

Roche $RHH­BY is now one step clos­er to re­al­iz­ing its block­buster am­bi­tions for Hem­li­bra, se­cur­ing a pri­or­i­ty re­view for a sec­ond, huge­ly im­por­tant in­di­ca­tion — he­mo­phil­ia A pa­tients who haven’t de­vel­oped re­sis­tance to fac­tor re­place­ment ther­a­py, more com­mon­ly known as pa­tients with­out fac­tor VI­II in­hibitors or non-in­hibitor pa­tients. The an­nounce­ment comes days af­ter the phar­ma gi­ant’s Genen­tech group rolled out a slate of new Phase III da­ta that backed Hem­li­bra’s case for re­duc­ing treat­ed bleeds: a 97% re­duc­tion com­pared with those with no pro­phy­lax­is and 68% com­pared to pre­vi­ous fac­tor VI­II treat­ment. Hem­li­bra was orig­i­nal­ly ap­proved to treat pa­tients with in­hibitors. An ap­proval here would make Roche an of­fi­cial ri­val of Shire, which has built a fran­chise around fac­tor re­place­ment ther­a­py. The FDA — hav­ing al­ready grant­ed the drug break­through sta­tus — has promised to give a de­ci­sion by Oc­to­ber 4, 2018.

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