No­var­tis con­fi­dent­ly breaks out mid-stage da­ta on Xo­lair com­peti­tor

Late last year, No­var­tis in­di­cat­ed its ex­per­i­men­tal ther­a­py lige­lizum­ab was Phase III ready af­ter it out­per­formed Xo­lair — the com­pa­ny’s Roche-part­nered chron­ic spon­ta­neous ur­ticaria ther­a­py that has lost patent pro­tec­tion — in a Phase II study.  On Tues­day, the Swiss drug­mak­er broke out some of the mid-stage da­ta that trig­gered its con­fi­dence.

In the 382-pa­tient tri­al, pa­tients were ei­ther giv­en lige­lizum­ab at a dose of 24 mg, 72 mg, or 240 mg, oma­l­izum­ab (Xo­lair) at a dose of 300 mg, or place­bo, ad­min­is­tered sub­cu­ta­neous­ly every 4 weeks for a pe­ri­od of 20 weeks, or a sin­gle 120-mg dose of lige­lizum­ab. Pa­tients in the study were al­ready on an­ti­his­t­a­mines.

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