EU Approves Myovant Sciences' RYEQO For Treatment Of Women With Uterine Fibroids

The European Commission has approved Myovant Sciences' (MYOV) the marketing authorization application for RYEQO--relugolix 40 mg, estradiol 1.0 mg, and norethindrone acetate 0.5 mg-- for the treatment of moderate to severe symptoms of uterine fibroids in adult women of reproductive age, with no limitation for duration of use.

The EC decision is valid in all 27 member states of the European Union, as well as Iceland, Norway, and Liechtenstein.

The approval was based on safety and efficacy data from the Phase 3 LIBERTY program, which consisted of two replicate, 24-week, multinational clinical studies, and supportive bone mineral density data from a randomized withdrawal study.

In March 2020, Myovant and Gedeon Richter reached license agreement for Gedeon Richter to commercialize relugolix combination tablet for uterine fibroids and endometriosis in Europe, the Commonwealth of Independent States including Russia, Latin America, Australia, and New Zealand.

As per the deal, Myovant received an upfront payment of $40 million and is eligible to receive up to $40 million in regulatory milestones and $107.5 million in sales milestones for a total of $147.5 million, and tiered royalties on net sales following regulatory approval.

Gedeon Richter will be responsible for local clinical development, manufacturing, and all commercialization for its territories.

Myovant and Gedeon Richter will also continue to collaborate on the marketing authorization application for endometriosis, which is expected to be submitted in the second half of calendar year 2021.

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