Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura) has announced positive results from the Phase 3b DAYLIGHT trial for fezolinetant, an investigational oral, nonhormonal compound designed to treat moderate to severe vasomotor symptoms (VMS) associated with menopause. Hot flashes and/or night sweats, common symptoms of menopause, make up the symptoms of VMS. The trial results are a promising development for those seeking a better treatment option for menopause-related VMS.
In a study of over 450 women, spanning a period of 24 weeks, fezolinetant 45 mg once daily was found to significantly reduce the frequency of moderate to severe VMS in comparison to placebo. Although serious treatment emergent adverse events such as COVID-19 and headache were reported in less than 5% of patients, this promising treatment has proven safe and effective. The comprehensive results of the study are set to be published and presented at an upcoming medical meeting.
Marci English, Vice President, Head of BioPharma Development, Astellas
We are thrilled that the first assessment of the DAYLIGHT study further confirms the ability of fezolinetant to reduce the occurrences of moderate to severe VMS related to menopause. These 24-week placebo-controlled results add to the accumulating evidence from the SKYLIGHT studies and shed more light on the safety and efficacy of fezolinetant for women who do not wish or are unable to take hormone therapy.
Astellas has been granted a major victory with the U.S. Food and Drug Administration (FDA) approving VEOZAH™, the fezolinetant, in May 2023. Astellas is now aiming for regulatory approval in Europe and other regions, and has already been gathering additional data from its DAYLIGHT study to support its health technology assessment (HTA) and reimbursement dossiers in Europe. This positive news has already been collected in its financial forecast for the current fiscal year ending March 31, 2024. It’s a massive success, and Astellas is looking forward to the bright future ahead!
The DAYLIGHT (NCT05033886) clinical trial is a revolutionary moment for menopausal women aged 40-65! This Phase 3b, double-blind, placebo-controlled trial is aimed at assessing the efficacy and safety of fezolinetant in the lives of those women enduring moderate to severe VMS and unable to seek hormone therapy. With 453 women enrolled from 69 sites in Canada, Europe and Turkey, we’re excited to see the changes this revolutionary study brings!
About the BRIGHT SKY™ Phase 3 Program
The two revolutionary BRIGHT SKY clinical trials, SKYLIGHT 1™ (NCT04003155) and SKYLIGHT 2™ (NCT04003142) enrolled an impressive 1,000 women with moderate to severe menopausal symptoms. An impressive 180 sites throughout the US, Canada and Europe were used to run the studies – which were double-blind and placebo-controlled for the first 12 weeks, followed by a treatment-extension period of 40 weeks.
SKYLIGHT 4™ (NCT04003389) goes even further, with a 52-week double-blind and placebo-controlled study investigating the long-term safety of fezolinetant. Over 1,800 women participated in the ambitious SKYLIGHT 4 trial at 180 sites throughout the US, Canada and Europe.
Fezolinetant is the FDA-approved solution to the discomfort that comes with menopausal hot flashes. This cleverly designed neurokinin 3 (NK3) receptor antagonist blocks a process in the brain’s thermoregulatory center (the hypothalamus), successfully reducing the intensity and frequency of those dreaded moderate to severe vasomotor symptoms. And the best part? It does all this naturally, without relying on hormones! So, if you’re dealing with frequent, uncomfortable hot flashes, why not give Fezolinetant a try—you may be surprised by the soothing relief it brings.
U.S. Important Safety Information
Do not use VEOZAH if you:
have severe kidney problems or kidney failure.
are taking certain medicines called CYP1A2 inhibitors. Ask your healthcare provider if you are not sure.
Before you use VEOZAH, tell your healthcare provider about all of your medical conditions, including if you:
have liver disease or problems.
have kidney problems.
have any medical conditions that may become worse while you are using VEOZAH.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. VEOZAH may affect the way other medicines work, and other medicines may affect how VEOZAH works.
VEOZAH can cause serious side effects, including:
- increased liver blood test values. Your healthcare provider will do a blood test to check your liver before you start taking VEOZAH. Your healthcare provider will also do this blood test at month 3, month 6, and month 9 after you start taking VEOZAH.
Call your healthcare provider right away if you have the following signs and symptoms of liver problems:
yellowing of the eyes or skin (jaundice)
pain in the right upper stomach (abdomen)
The most common side effects of VEOZAH include:
stomach (abdominal) pain
difficulty sleeping (insomnia)
hot flashes or hot flushes
These are not all the possible side effects of VEOZAH. Tell your healthcare provider if you have any side effect that bothers you or does not go away.
At Astellas Pharma, we are driving the healthcare revolution by utilizing a Focus Area Approach that brings us closer to discovering effective treatments for serious diseases. Thanks to our advanced Rx+® healthcare solutions, we’re able to combine our expertise with outside resources to develop groundbreaking innovations that will improve the lives of those who need it most. With our presence in over 70 countries worldwide, Astellas brings value to patients and creates a lasting impact on healthcare.
As a leading global pharmaceutical leader, Astellas’ impressive performance is underpinned by its commitment to research, development and innovation. However, many external economic, legal and regulatory factors could impede progress, together with fluctuations in currency, delays in launches, and challenges in marketing existing and new products.
As such, Astellas is ever-mindful of its intellectual property and rigorously safeguards it from third-party infringement. This press release serves to advance its plans while staying mindful of the potential risks and uncertainties. Furthermore, it is important to note that the information included pertains to products in development and should not serve as medical advice.