Pfizer and Myovant’s menstrual blood loss treatment reports 78% effectiveness

pharmafile | March 24, 2021 | News story | Research and Development Myovant, Pfizer, Phase III trial, fibroids, uterine fibroids 

Pfizer and Myovant Science’s relugolix treatment to reduce menstrual blood loss in women with uterine fibroids has shown promising results in its Phase III trial.

The study reported that 78.4% of women who continued on relugolix combination therapy remained responders – meaning their menstrual blood loss was contained to less than 80 ml – up to week 76 of treatment, compared with 15.1% of women who discontinued treatment at week 52.

The randomised LIBERTY trial, which featured 229 participants, also found that 69.8% of women who continued relugolix combination therapy remained responders after two years, whereas 88.3% of women who stopped taking treatment relapsed with heavy menstrual bleeding, on average 5.9 weeks after discontinuation.

The treatment is a once-daily pill, taken in combination with other therapies.

It is estimated that up to 80% of women will develop uterine fibroids at some point in their life. Around one in three of these will develop symptoms, including heavy menstrual bleeding.

Dr Ayman Al-Hendy PhD, Professor of Obstetrics and Gynecology at University of Chicago and LIBERTY Program Steering Committee Member, said: “Since many women with uterine fibroids spend years struggling to manage their symptoms, there is a critical need for non-invasive long-term treatment options.

“Data from the LIBERTY study demonstrate the potential value of continued treatment for women with uterine fibroids, with those receiving relugolix combination therapy in the study experiencing meaningful symptom relief for up to two years.”

Dr James Rusnak PhD, Senior Vice President, and Chief Development Officer of Internal Medicine and Hospital, Global Product Development at Pfizer, added: “Uterine fibroids can affect many women during their lifetime with uncomfortable symptoms, such as heavy menstrual bleeding. We believe that these study results offer encouraging data in support of longer-term efficacy in women suffering from uterine fibroids.”

Jack Goddard

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