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Myovant Plans Q4 Uterine Fibroid Drug Filing In A Showdown With AbbVie

 
• By Jessica Merrill

A second Phase III trial testing relugolix met its primary endpoint, putting Myovant in a tight race with AbbVie to bring the first drug to market for women with uterine fibroids.

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Myovant Sciences Ltd. and AbbVie Inc. are headed toward a showdown in the potentially lucrative commercial market for women with uterine fibroids. Both companies are on track to file new drug applications with the US Food and Drug Administration this year for the first drugs to reduce bleeding in women with uterine fibroids.

Myovant reconfirmed it is on track to meet its NDA filing timeline for relugolix in late 2019, announcing on 23 July that the second of two Phase III clinical trials for the drug met the primary endpoint and six secondary endpoints in women with uterine fibroids. The results confirm previously announced data from the first Phase III study, LIBERTY 1

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