EMA accepts Astellas' filing for fezolinetant

The European Medicines Agency (EMA) has accepted the marketing authorization application (MAA) for Japanese drugmaker Astellas Pharma’s (TYO: 4503) fezolinetant, an investigational oral, non-hormonal compound seeking approval for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause. VMS, characterized by hot flashes and/or night sweats, are common symptoms of menopause.

Supporting the filing are results from the BRIGHT SKY program, which included three Phase III clinical trials that collectively enrolled over 2,800 women with VMS across Europe, the USA and Canada. Results from the SKYLIGHT 1 and SKYLIGHT 2 pivotal trials characterize the efficacy and safety of fezolinetant for the treatment of moderate to severe VMS associated with menopause. Data from the SKYLIGHT 4 safety study further characterizes the long-term safety profile of fezolinetant. Within the MAA, Astellas proposes a 45mg daily dose, which is subject to the EMA’s review.

Expected to be a growth driver for Astellas