Linzagolix reduces heavy
menstrual bleeding caused by uterine fibroids
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
Source: Healio Primary Care
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