Myovant Sciences (MYOV 2.34%) reported positive results from the late-stage Liberty extension study testing its relugolix combination therapy, which contains relugolix, estradiol, and norethindrone acetate, in patients with uterine fibroids.
The biotech had already successfully tested relugolix in two pivotal clinical trials -- dubbed Liberty 1 and 2 -- but those studies only tested how patients responded to the drug for 24 weeks. Since the combination therapy may not be a cure, Myovant Sciences allowed patients from those two studies to enter this extension study, testing it for a total of 52 weeks.
After a year of treatment, 87.7% of the women had responded to the therapy. The drug produced an 89.9% average reduction in menstrual blood loss from baseline.
Myovant plans to submit the results of Liberty 1 and 2 and the extension study to the Food and Drug Administration in April, setting it up for a potential approval late this year or early next year.
There's a substantial need for the drug: Approximately 250,000 women in the U.S. undergo hysterectomies to deal with uterine fibroids each year. "A non-invasive treatment option that could provide long-term symptom improvement and ease of use would be a game-changer for physicians and millions of women who suffer from this common condition," Ayman Al-Hendy, professor of obstetrics and gynecology and director of translational research at the University of Illinois College of Medicine, said in the press release announcing the results.
Myovant will run another year-long clinical trial in which patients will either continue to receive the relugolix combination therapy or will be switched to placebo to see if their symptoms return. If the multiyear maintenance therapy continues to help patients, that could increase the potential market for the treatment substantially.