Al­ler­gan aces an­oth­er promis­ing PhI­II on uter­ine fi­broid ther­a­py, with plans to hus­tle the bun­dle to the FDA

Al­ler­gan and its part­ners at Gedeon Richter have aced the sec­ond Phase III study of ulipristal ac­etate for uter­ine fi­broids, set­ting up an FDA ap­pli­ca­tion in the sec­ond half of this year.

Like the first VENUS study, the sec­ond aced all the co-pri­ma­ry and sec­ondary end­points, with sig­nif­i­cant­ly im­proved rates of an ab­sence of bleed­ing for both the 10 mg and 5 mg arms — 54.8% and 42% — com­pared to none of the pa­tients in the place­bo arm.

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