The European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) on December 17 recommended approval of linzagolix (Yselty, ObsEva), an oral gonadotropin-releasing hormone (GnRH) antagonist, for the management of moderate to severe symptoms of uterine fibroids (UFs) in adult women of reproductive age.
If approved, linzagolix ― which is taken once per day ― would become the first GnRH receptor antagonist with a nonhormonal option to reach the market. The US Food and Drug Administration (FDA) in November accepted ObsEva’s new drug application for the medication, with a decision expected by September 2022.
“The positive CHMP opinion is an important milestone for millions of women in the EU living with UF to address the diverse medical needs of the women who suffer from this condition,” said Brian O’Callaghan, CEO of ObsEva, in a statement. “We will continue our productive, ongoing dialogue with EMA toward potential marketing authorization in the EU, and in parallel, continue to work with the FDA to advance linzagolix through the U.S. regulatory process.”
The committee’s positive opinion was based on 52-week results from PRIMROSE 1 and PRIMROSE 2 phase 3 trials, involving more than 1000 patients in the United States and Europe, as well as results from 76-week follow-up studies of patients in those trials. The two phase 3 trials assessed a 200-mg and 100-mg dose of linzagolix, with and without hormone add-back therapy (ABT; 1 mg estradiol and 0.5 mg norethisterone acetate).
According to ObsEVA, both trials met their primary endpoints, with all doses showing statistically significant and clinically relevant reductions in heavy menstrual bleeding (HMB) compared to placebo. The trials also achieved several secondary endpoints, including reduction in pain, rates of amenorrhea, time to reduced HMB, and amenorrhea; and, for the high dose without ABT, reductions in uterine and fibroid volume, the company said.
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