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Myovant's Relugolix May Be Competitive With AbbVie Drug In Uterine Fibroids

 
• By Joseph Haas

Relugolix meets primary and six key secondary endpoints in first Phase III UF study. Magnitude of benefit for primary endpoint does not equal AbbVie’s elagolix, but Myovant thinks it will offer safety, tolerability and convenience advantages.

uterine-fibroids
AbbVie, Myovant and ObsEva are competing to bring a GnRH antagonist to market for UF

The competition to bring an oral gonadotropin-releasing hormone (GnRH) receptor antagonist to market for uterine fibroids grew more complex on 14 May when Myovant Sciences Ltd. said relugolix hit its primary endpoint and six key secondary endpoints in the first of two Phase III trials. However, its stock price tumbled on concerns that the drug's magnitude of benefit did not match what AbbVie Inc. showed in Phase III with elagolix.

Relugolix and elagolix – US approved in 2018 as Orilissa to treat endometriosis – are two of three oral GnRH receptor antagonists in Phase III for uterine fibroids (UF), along with ObsEva SA’s linzagolix. Both AbbVie and Myovant, a publicly traded Roivant Sciences GmbH portfolio company, hope to file their agents for FDA approval before the end of 2019, while ObsEva says it is on track to report Phase III trials for its drug in the fourth quarter of 2019 and first quarter of 2020

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