Astellas Releases Topline Results from  a Long-Term Phase 3 SKYLIGHT 4 Safety Study of  Fezolinetant 

0 173

Astellas Pharma Inc. today announced topline study results from the Phase 3 SKYLIGHT 4 clinical trial, which will support future regulatory filing submissions for fezolinetant, an investigational oral, nonhormonal compound being studied for the treatment of moderate to severe vasomotor symptoms associated with menopause (VMS). VMS is a frequent symptom of menopause that is characterised by hot flashes (also known as hot flushes) and/or nocturnal sweats.

SKYLIGHT 4 is a randomized, placebo-controlled, double-blind Phase 3 clinical trial involving nearly 1,800 women, with the goal of determining the long-term (52-week) safety of fezolinetant in women seeking relief from VMS caused by menopause. The study’s main goals were to assess the effects of fezolinetant on endometrial health as well as the drug’s long-term safety and tolerability. The primary goal of endometrial health was met, while headache and COVID-19 were the most common treatment-emergent adverse events (TEAE), which were similar to placebo. The topline data will be used to further evaluate fezolinetant’s long-term safety profile and will be used to influence future regulatory submissions. Detailed findings will be submitted for publication and discussion at upcoming medical conferences.

“Based on our initial assessment, we are pleased with the outcome of the SKYLIGHT 4 study, which further characterizes the long-term safety of fezolinetant. With these fezolinetant data, we are hopeful that we will have the opportunity to deliver a first-in-class, nonhormonal treatment option for moderate to severe VMS associated with menopause,”

said Nancy Martin, M.D., PharmD, Vice President, Global Medical Head, Medical Specialties, Astellas. 

“Vasomotor symptoms are often reported as the most bothersome symptoms of menopause, yet there has been very little innovation in this therapeutic area. I am excited by the potential of a new non-hormonal treatment option for women experiencing moderate to severe VMS associated with menopause,”

said Genevieve Neal-Perry, M.D., Ph.D., Chair, UNC School of Medicine Department of Obstetrics and Gynecology. 

The SKYLIGHT 4 findings, along with the results from two pivotal Phase 3 clinical trials, SKYLIGHT 1 and SKYLIGHT 2, will provide the foundational data for regulatory submissions in the U.S. and Europe.

Fezolinetant is an investigational selective neurokinin-3 (NK3) receptor, antagonist. The safety and efficacy of fezolinetant are under investigation and have not been established. If approved by regulatory authorities, fezolinetant would be a first-in-class, nonhormonal treatment option to reduce the frequency and severity of VMS associated with menopause.

Leave A Reply

Your email address will not be published.