EMA Panel Backs Linzagolix for Uterine Fibroid Symptoms
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 is expected to be the first GnRH receptor antagonist with an option that isn’t hormone-based to be on the market. The US Food and Drug Administration (FDA) in November endorsed ObsEva’s application for a new drug to the medication, with a decision expected by September 2022.
“The positive CHMP opinion is a significant achievement for millions of women across the EU living with UF to address the various medical needs of the women suffering from this condition,” said Brian O’Callaghan, CEO of ObsEva, in an announcement. “We will continue to engage in a productive, ongoing dialog with EMA regarding a possible marketing authorization in Europe, and in tandem we will continue to collaborate with FDA to further develop linzagolix through the U.S. regulatory process.”
The committee’s positive opinion was based on results from 52 weeks from PRIMROSE 1 and PRIMROSE 2 phase 3 trials which involved more than 1000 patients in the United States and Europe, as well as results from study follow-ups of patients for 76 weeks who participated in those trials. The phase 3 trials tested 100 mg or 200 mg doses of linzagolix with or without hormone add-back therapy (ABT 1 mg estradiol, and 0.5 mg norethisterone.acetate).
ObsEVA said that both trials met their primary objectives. All doses showed statistically significant and clinically significant reductions in heavy periods (HMB) when contrasted with placebo. The company also stated that the trials also met secondary criteria such as a decrease in pain, amenorrhea rates, amenorrhea, and time to reduce HMB. For the high dose without ABT, there were also reductions in the volume of the uterus and the volume of fibroid.
Content Source: https://www.medscape.com/viewarticle/965129?src=rss