Astellas Receives Chinese Clinical Approval for Fezolinetant in Moderate to Severe Vasomotor Symptoms

On January 10, Astellas’ fezolinetant tablets received implicit clinical trial approval in China for the treatment of moderate to severe vasomotor symptoms (VMS).

Vasomotor Symptoms (VMS), referring to hot flashes and night sweats in postmenopausal women. It is estimated that approximately 57% of women aged 40–64 worldwide experience hot flashes and night sweats. Patients with this condition often suffer from anxiety, irritability, reduced work productivity, and depression, which significantly impair their sleep and quality of life.

Fezolinetant is an oral, non-hormonal compound developed by Ogeda that normalizes KNDy neuron activity by blocking neurokinin B (NKB) signaling, thereby regulating the thermoregulatory center and reducing the frequency and severity of hot flashes. In 2017, Astellas acquired Ogeda for €500 million (equivalent to $534 million) to obtain this drug.

Results from the Phase IIb dose-ranging study of fezolinetant for the treatment of vasomotor symptoms, presented at the 2019 Annual Meeting of the Endocrine Society (ENDO), demonstrated that, at Weeks 4 and 12 of treatment, the mean changes in the frequency and severity of moderate-to-severe VMS were statistically significant in the fezolinetant group compared with the placebo group.

In terms of safety, the incidence of adverse events was similar across treatment groups; most were mild or moderate in severity, and no deaths or treatment-related serious adverse events occurred.