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2022-10-03| Trials & Approvals

EMA Begins Regulatory Review For Astellas’ Fezolinetant

by Joy Lin
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The European Medicines Agency (EMA) has accepted Astellas’ marketing application for fezolinetant, a non-hormonal neurokinin 3 (NK3) inhibitor designed to treat moderate-to-severe vasomotor symptoms (VMS) associated with menopause. 

“The EMA’s acceptance of our MAA (marketing authorization application) for fezolinetant brings us one step closer to advancing a potential first-in-class non-hormonal treatment option for women in Europe who experience VMS associated with menopause, similar to the FDA acceptance of our NDA (new drug application) for women in the US,” said Ahsan Arozullah, M.D., M.P.H., Senior Vice President and Head of Development Therapeutic Areas, Astellas. The FDA accepted the NDA for fezolinetant this August. 

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

Nonhormonal Treatment For VMS

More than half of women going through menopause experience VMS, such as hot flashes and/ or night sweats. Because menopause is caused by lower hormone levels, hormone replacement therapy is effective at relieving symptoms. However, hormonal treatments take time to take effect and are contraindicated in many women, such as breast cancer patients. 

Fezolinetant takes the non-hormonal route, blocking the NK3 receptor to prevent neurokinin B binding on the kisspeptin/neurokinin/dynorphin (INDy) neuron in the hypothalamus. This reduces the frequency and severity of VMS. 

Astellas is basing its marketing application on results from the Bright Sky program, which includes three Phase 3 trials that enrolled over 2,800 women with VMS across Europe, the US, and Canada. Topline data from the pivotal trials Skylight 1 and Skylight 2 demonstrated that fezolinetant improved VMS symptoms, while Skylight 4 further characterizes the long-term safety profile of fezolinetant.

Efficacy Miss In Asia 

Not all has been smooth sailing for the drug, which failed its Phase 3 Moonlight 1 trial in Asia this March. The study investigated the efficacy of fezolinetant in 302 women in China, Korea, and Taiwan. While Astellas recorded improvements in hot flashes in patients treated with fezolinetant, the difference from placebo did not reach predefined efficacy endpoints. 

While Astellas continues to review fezolinetant’s failure in Asia, the company recently reported positive topline results from the Moonlight 3 long-term safety study of fezolinetant. The 52-week Phase 3 trial found that the frequency and severity of adverse events were consistent with previous Phase 3 trials of fezolinetant. 

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