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VENUS II Paves Way For Allergan's Ulipristal NDA In Uterine Fibroids

 
• By Emily Hayes

Ulipristal meets all primary and secondary endpoints in the pivotal VENUS II study, supporting an NDA for uterine fibroids in the second half of 2017.

chemist

Allergan PLC/Gedeon Richter Ltd. are on track for a planned NDA filing of oral ulipristal acetate for the treatment of uterine fibroids in the second half of this year, after releasing positive Phase III data on Jan. 17.

The partners announced that the drug, given at two different doses (5 mg and 10 mg), met all co-primary and secondary endpoints in the Phase III VENUS II study that enrolled 432 pre-menopausal women. The drug also succeeded in the 157-patient, Phase III VENUS I study in 2016

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