Esmya Approaches The U.S.

May 11, 2016 10:35 AM ETAllergan plc (AGN)9 Comments
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It looks as if Allergan’s (NYSE:AGN) uterine fibroid drug Esmya is finally going to break America. Four years after it reached market in Europe, the selective progesterone receptor modulator has hit big in the first of its pivotal US trials, and Allergan’s shares rose 6% yesterday as investors consider its potential sales – currently forecast at over $500m.

Approval is not quite certain yet. A second phase III trial will have to read out before Allergan can file with the FDA, and that is not due until early next year. Still, the win in the Venus I trial was emphatic, and if Venus II is similarly impressive, some analysts believe that global sales could climb closer to $1bn.


The Venus I study forms part of the second attempt to get Esmya to the US as a therapy for fibroids. The first was shelved in 2012 (Allergan's uterine fibroid pill and BioMarin's Kuvan follow-on, February 12, 2016).

Venus I enrolled 157 premenopausal women, 101 of whom were randomly assigned a single 5mg or 10mg Esmya (ulipristal acetate) pill each day for 12 weeks, and 56 of whom received placebo. The drug did not disappoint: 58% of the patients given 10mg of the drug and 47% given 5mg had no abnormal bleeding, one of the co-primary endpoints, compared with 1.8% on placebo.

The other co-primary endpoint, time to absence of bleeding, was also met with significance by both treatment arms, Allergan said, though the company did not give details.

As for the secondary efficacy endpoints, 58% of patients given the 10mg dose and 43% of those given the 5mg dose achieved absence of bleeding from day 11 to the end of treatment; none of the placebo-treated patients achieved this. Improvement from baseline on a scale designed to measure fibroid patients’ quality of life was 59 points in

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