2022-08-18| Trials & Approvals

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

by Max Heirich
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On August 18, Astellas Pharmaceuticals announced that the United States Food and Drug Administration (FDA) accepted their New Drug Application (NDA) for fezolinetant. The FDA made its decision based on the results of the BRIGHT SKY program, a program involving three Phase 3 clinical trials. Fezolinetant treats moderate to severe vasomotor symptoms (VMS) associated with menopause.

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Fezolinetant Treats Severe Symptoms of Menopause

VMS, otherwise known as hot flashes or night sweats, is one of the most common symptoms of menopause. These episodes consist of profuse heat, sweating, and flushing in the head, neck, chest, and upper back areas. The SWAN study, a longitudinal study of the menopausal transition, saw 60-80% of the 3,302 midlife women enrolled experience some form of VMS. 

Changes in gonadal hormones cause the temperature dysfunction seen in VMS. Usually, hormones produced by the gonad stimulate sexual responses in adults. However, the menopausal transition interrupts these functions, leading to VMS and sleep disturbances, depression, increased anxiety, cognitive difficulties, and reduced quality of life.

The current standard of treatment for VMS is hormone replacement therapy. These treatments replace hormones like estrogen that the body stops producing during menopause. An example of such a treatment is Duramed Pharmaceuticals’ Cenestin. Approved in 1999, Cenestin replaces the body’s depleted estrogen with a mixture of nine synthetic estrogens. 

However, doctors do not recommend estrogen replacement therapies to patients with a history of breast cancer as these treatments can cause breast cells to grow.

Fezolinetant goes against the norm to treat severe symptoms of menopause. Rather than using hormones, Astellas’ new drug inhibits the binding of peptide Neurokinin B to specific neurons in a patient’s hypothalamus. This blocking results in reduced frequency and severity of VMS. 

The BRIGHTSKY Program Yields Topline Results

The FDA based its acceptance on the results from three clinical trials involved in the BRIGHT SKY program. The program tested the efficacy and safety of fezolinetant between the three Phase 3 Trials, SKYLIGHT 1, SKYLIGHT 2, and SKYLIGHT 4.

SKYLIGHT 1 and 2 demonstrated that the overall frequency of VMS fell in patients who took fezolinetant. SKYLIGHT 4 showed that patients tolerated the treatment well over the period of a year.

On the acceptance of the NDA, Ahsan Arozullah, M.D., M.P.H., Senior Vice President and Head of Development Therapeutic Areas, at Astellas, said, “The FDA’s acceptance of our NDA for fezolinetant brings us one step closer to advancing care for women in the U.S. who experience VMS. We look forward to the FDA’s review of our application, and the potential to offer a first-in-class nonhormonal treatment option to reduce the frequency and severity of moderate to severe VMS associated with menopause.”

With the NDA for fezolinetant accepted, the FDA’s review team will begin the analysis of the data. Within six to ten months, their review team will decide whether or not they will approve fezolinetant.

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