#Japan #Tokyo #Astellas Pharma #VEOZAH #fezolinetant

Astellas Presents Promising Preliminary Data on VEOZAH™

Astellas Pharma Inc. has released preliminary data from the OPTION-VMS Phase IV observational study, showcasing the efficacy of VEOZAH™ (fezolinetant) in treating moderate to severe vasomotor symptoms (VMS) associated with menopause. This study marks a pivotal point in understanding the real-world effectiveness of fezolinetant as it demonstrates significant improvements in various health indicators for women aged 40-75 suffering from menopausal symptoms.

Effectiveness of VEOZAH in Alleviating Symptoms

The OPTION-VMS study involved over 900 women who were experiencing bothersome VMS, such as hot flashes and night sweats, which are common during menopause. The women were prescribed fezolinetant, a non-hormonal treatment option. The preliminary results revealed statistically significant reductions in VMS bother, measured through the Menopause-Specific Quality of Life (MENQOL) questionnaire. Improvements were noted as early as week 4, exceeding expectations with substantial enhancements visible in both subjective and objective sleep measures by week 12.

The study indicates that fezolinetant offers more than just a respite from discomfort. Improvements in sleep quality—assessed via the Patient Reported Outcomes Measurement Information System (PROMIS)—showed encouraging trends, with reductions in wakefulness after sleep onset (WASO) and increased sleep efficiency as reported through actigraphy.

Impact on Work Productivity

Notably, beyond symptom relief, fezolinetant's effect on work productivity was highlighted. The initial analysis revealed significant improvements in activity impairment and overall work productivity loss among participants, as well as lower absenteeism due to severe menopausal symptoms. This data suggests that addressing VMS could relieve a financial burden on both affected women and the workforce at large—crucial as studies estimate that menopausal symptoms impact around one-third of working-age women.

Safety Profile and Broader Implications

Astellas also emphasized the safety profile of fezolinetant within the study cohort, reporting low incidences of treatment-emergent adverse events, consistent with previous clinical trials. No new safety concerns were identified in this preliminary data. Understanding the safety of new treatments is vital, especially considering the economic consequences of menopausal symptoms, which often drive women out of the workforce or reduce their working hours due to debilitating symptoms.

Dr. Genevieve Neal-Perry from the UNC School of Medicine acknowledged the significance of these findings, stating that the results from the study address the growing population of women who may suffer from disruptive vasomotor symptoms, projected to reach 1.2 billion globally by 2030.

Conclusion

Astellas remains committed to advancing treatments for women's health, and the new data on VEOZAH reinforces their dedication to improving the quality of life for menopausal women. As more information from the OPTION-VMS study becomes available, it is anticipated that further findings will enhance our understanding of VEOZAH's long-term benefits in real-world settings. Not only does this study pave the way for innovative treatment options, but it also underscores the crucial interplay between menopausal health and overall productivity, revealing a pathway to improving life quality for millions of women experiencing menopause.