New Phase III data support regulatory filing for fezolinetant

Shares of Japanese drug major Astellas Pharma (TYO: 4503) rose 2.9% to 1,845 yen in morning trading, after it announced positive top-line results from the Phase III SKYLIGHT 4 clinical trial investigating the long-term safety of fezolinetant, an investigational oral, non-hormonal compound being studied for the treatment of moderate to severe vasomotor symptoms associated with menopause (VMS) which will support future regulatory filing submissions. VMS, characterized by hot flashes (also called hot flushes) and/or night sweats, are common symptoms of menopause.

SKYLIGHT 4 is a randomized, placebo-controlled, double-blind Phase III clinical trial in over 1,800 women investigating the long-term (52-week) safety of fezolinetant in women seeking treatment for relief of VMS associated with menopause. The study’s primary objectives were to evaluate the effect of fezolinetant on endometrial health and the long-term safety and tolerability of fezolinetant. The primary endpoint assessing endometrial health was achieved and the most common treatment emergent adverse events (TEAE) were headache and COVID-19, consistent with placebo. The top-line data further characterize the long-term safety profile of fezolinetant and will inform future regulatory filings. Detailed results will be submitted for publication and for consideration at upcoming medical meetings.

The SKYLIGHT 4 findings, along with the results from two pivotal Phase III clinical trials, SKYLIGHT 1 and SKYLIGHT 2, will provide the foundational data for regulatory submissions in the USA and Europe., the company stated.