Astellas Pharma, a Tokyo-based pharmaceutical company, has achieved a significant milestone with the approval of its groundbreaking drug by the U.S. Food and Drug Administration (FDA). The drug, fezolinetant, has been given the green light to treat hot flashes and night sweats caused by menopause, making it the first therapy to target a specific receptor in the central nervous system for alleviating these symptoms.
The Disruptive Symptoms
Hot flashes and night sweats are among the most distressing and disruptive symptoms experienced by women going through menopause. As estrogen and progesterone production decline during this transitional phase of life, the resulting hormonal imbalance can trigger sudden and intense feelings of warmth, affecting body temperature regulation. While hormone therapy has traditionally been the go-to treatment for these vasomotor symptoms, it carries potential risks, such as increased chances of stroke, blood clots, or heart attack.
Furthermore, women with a history of cardiovascular problems may not be suitable candidates for hormone therapy, leaving them with limited options. Astellas Pharma’s fezolinetant offers a promising non-hormonal alternative for these individuals.
Next Steps Following The Approval
Veozah, the brand name under which the once-a-day pill will be marketed, has been approved for the treatment of moderate-to-severe vasomotor symptoms resulting from menopause. Astellas Pharma plans to make Veozah available within three weeks following the FDA’s Friday approval. The wholesale price for a 30-day supply of the drug is set at $550, according to an email from the company.
What is Veozah?
Veozah is a small molecule designed to block the neurokinin 3 (NK3) receptor found in the central nervous system, which plays a crucial role in regulating body temperature. The FDA‘s approval of the Astellas Pharma drug was based on the results of two Phase 3 studies, each lasting 12 weeks. The primary objective of these studies was to evaluate the reduction in the severity and frequency of moderate-to-severe vasomotor symptoms.
The results demonstrated that treatment with Veozah led to statistically significant improvements in symptom severity and frequency. The findings were published in March in the esteemed medical journal The Lancet.
Following the completion of the initial 12-week studies, participants continued to a 40-week extension study to further assess the safety of Veozah. Those who had been receiving the drug throughout the trials maintained their treatment, while those who initially received a placebo were transitioned to the Astellas therapy. The most common adverse reactions reported during the studies included abdominal pain, diarrhea, insomnia, back pain, hot flashes, and elevated liver enzymes.
The elevation in liver enzymes observed could indicate potential drug toxicity. Consequently, Veozah’s label will include a warning about the drug’s potential to cause liver injury. The FDA recommends that patients undergo blood work before initiating treatment and receive regular monitoring throughout the therapy to detect any liver-related complications. It should be noted that individuals with cirrhosis, severe kidney damage, or end-stage renal disease should refrain from taking the Astellas drug.
First Approved NK3-blocking Drug
While regulatory applications for Veozah are still pending in the European Union, Switzerland, and Australia, the FDA’s decision has firmly established Veozah as the first approved NK3-blocking drug. Other pharmaceutical companies have also targeted this receptor to address menopausal symptoms.