Linzagolix reduces heavy menstrual bleeding caused by uterine fibroids
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Results from a phase 3 trial of linzagolix showed that the therapy was effective in reducing heavy menstrual bleeding caused by uterine fibroids, according to a press release issued by the manufacturer, ObsEva.
“Women with uterine fibroids need nonsurgical alternatives to reduce the often unbearable effects of heavy menstrual bleeding,” Hugh Taylor, MD, professor and chair of obstetrics and gynecology at Yale University, said in the release. “The prospects for a medical treatment with multiple dosing options would address a need for this diverse population of women.”
The trial, PRIMROSE 2, was conducted in Europe and the United States, and included 535 women with heavy menstrual bleeding caused by uterine fibroids.
Researchers assessed the efficacy and safety of daily oral linzagolix doses of 100 mg and 200 mg with and without hormonal add-back therapy (ABT) in reducing heavy menstrual bleeding, according to the press release.
Women were considered responders to treatment if they had menstrual blood loss of 80 mL or less at 24 weeks and at least a 50% reduction in menstrual blood loss from baseline.
The responder rate was 93.9% (P < 0.001) among women who received 200 mg of linzagolix with ABT and 56.7% in those who received 100 mg without ABT (P < 0.001). In comparison, the responder rate of those in the placebo group was 29.4% (P < 0.001).
Both doses achieved secondary endpoints of significant rates of amenorrhea, reduced pain and improved quality of life among participants. Researchers also observed a significant improvement in hemoglobin levels with both doses, along with fewer days of bleeding and decreased uterine volume.
Adverse events — the most common of which were headache, anemia, and hot flashes — occurred in less than 5% of patients.
“The excellent responder rates for the 200 mg with ABT and the 100 mg dose without ABT strongly support our dual strategy of development for linzagolix,” Ernest Loumaye, MD, PhD, CEO and co-founder of ObsEva, said in the press release.
Loumaye explained in the release that if the company’s second study of linzagolix, PRIMROSE 1, yields positive results, it would submit a marketing authorization application to the European Medicine Agency by the end of 2020 and a New Drug Application to the FDA in early 2021. – by Erin Michael
Disclosures: Loumaye is CEO and co-founder of ObsEva. Healio Primary Care was unable to confirm Taylor’s relevant financial disclosures at the time of publication.