2022-09-05| Trials & Approvals

Further Clinical Trial Results Reinforce Prior Findings For Astellas’ Menopause Treatment

by Max Heirich
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On September 5, Astellas Pharmaceuticals announced topline results from their Phase 3 clinical trial investigating fezolinetant. Fezolinetant is a nonhormonal compound treating moderate to severe vasomotor symptoms (VMS) associated with menopause. While currently not approved by any regulatory agency globally, a New Drug Application for fezolinetant is under review by the United States Food and Drug Administration (FDA). 

Related Article: Astellas Pharmaceuticals’ Novel Non-hormonal Treatment for Severe Symptoms of Menopause Approved by the FDA

Fezolinetant, its History, and Possible Approvals 

Fezolinetant treats hot flashes or night sweats associated with menopause. Changes in gonadal hormones caused by the menopausal transition result in these events. The SWAN study found that these episodes affect 60-80% of midlife women. 

Currently, the standard treatment for VMS is hormone replacement therapy. However, it is not recommended for patients with a history of breast cancer to take these drugs as they can cause breast cells to grow. 

Fezolinetant mitigates these events by inhibiting the binding of peptide Neurokinin B to specific neurons in a patient’s hypothalamus. As a result, VMS occurs less frequently and not as severely.

Though not currently approved by any regulatory body, Astellas has made various submissions for the medication. For example, in August, the company submitted an NDA for fezolinetant to the FDA. Three clinical trials back the submission under the BRIGHTSKY program: SKYLIGHT 1, SKYLIGHT 2, and SKYLIGHT 4. All three trials demonstrate the efficacy and safety of fezolinetant.

While the NDA is under review, another Phase 3 trial concluded and demonstrated further evidence backing the new menopause treatment. 

MOONLIGHT 3 Results Mirror the BRIGHTSKY Program 

MOONLIGHT 3 is a Phase 3 study investigating the long-term safety and tolerability of fezolinetant. Over 52 weeks, 150 women with VMS associated with menopause took 30mg of fezolinetant once daily. The primary endpoint was the frequency and severity of adverse events, consistent with prior Phase 3 Studies of fezolinetant. Detailed results are currently unavailable; their submission for publication will occur “in the near future.”

On the results, Ahsan Arozullah, MD, MPH, Senior Vice President and Head of Development Therapeutic Areas at Astellas, said, “The topline results from the MOONLIGHT 3 study are very encouraging and, upon initial review, further support the long-term safety of fezolinetant.”

It is unknown how these results will affect the FDA’s ongoing review of fezolinetant. However, at the very least, the MOONLIGHT 3 results seem to be another win for Astellas’ new menopause treatment. 

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