What is the relevant marketing information about fezolinetant?

Fezolinetant is the first approved oral NK3 receptor antagonist, and its launch time is a milestone worldwide. In the United States, Fezonatant was officially approved for marketing on May 12, 2023, under the trade name Veozah, and is used to relieve the symptoms of moderate to severe hot flashes in menopausal women.

The U.S. Food and Drug Administration's (FDA) approval was based on the results of multiple randomized, double-blind, controlled clinical trials, showing that fezonatant can significantly reduce the frequency and severity of hot flashes while having good safety and tolerability. Compared with traditional hormone therapy, filazonatant does not require the use of estrogen or progestin, making it particularly suitable for patients at risk for cardiovascular disease, blood clots, or hormone-dependent tumors.

In Europe, Fezonatant was approved on December 7, 2023, under the trade name Veoza, for the management of the same indication. The European Medicines Agency (EMA) approved fezonatant on a basis similar to that in the United States, emphasizing its high selectivity for NK3 receptors, good pharmacokinetic properties, and safety for long-term use. After being launched on the market, fezonatant has been gradually included in the menopausal treatment guidelines of some countries and has become an important part of non-hormonal treatment options.

Clinically, the dosage regimen of fezonatant is daily oral administration, and the dose can be adjusted according to the patient's symptoms and tolerance. After the drug is marketed, doctors can decide whether it is appropriate to use fezonetan by evaluating the patient's previous treatment history, symptom severity, and comorbid disease conditions. Overseas guidelines also recommend monitoring liver function and overall tolerance during use to ensure the safety and long-term effectiveness of the treatment.

Overall, the launch of filazonetant provides a safe and effective non-hormonal treatment option for menopausal women, bringing new hope to patients who are unable or unwilling to accept traditional hormone therapy.

Reference materials:https://www.veozah.com/