Astellas Pharma Inc. has been granted an extended priority review of its investigational agent ‘Fezolinetant’ by the U.S. Food and Drug Administration. Fezolinetant is being developed to treat moderate to severe vasomotor symptoms (VMS) due to menopause. The original Prescription Drug User Fee Act (PDUFA) goal date has been extended by three months, to May 22, 2023, giving Astellas more time to complete its review. With this extension, the company is hopeful that Fezolinetant will prove to be a successful treatment that will bring relief to those suffering from VMS.
At Astellas, we are confident in the power of fezolinetant to bring relief to women experiencing moderate to severe VMS due to menopause. We remain dedicated to working with the FDA as they review our NDA for this promising treatment and look forward to the potential benefits it could bring.
Astellas’ financial results for the current fiscal year ending March 31, 2023 are expected to remain largely unaffected by this matter, with any impact being minimal.
About Fezolinetant
Fezolinetant is an exciting new oral, nonhormonal therapy currently being tested for the treatment of moderate to severe VMS due to menopause. It works by blocking the binding of neurokinin B on the KNDy neuron, a vital part of the thermoregulatory center of the brain, to reduce the frequency and severity of moderate to severe VMS. While the safety and efficacy of fezolinetant is still under investigation, this innovative new therapy provides hope for menopausal women looking for relief from their symptoms.
About Astellas
At Astellas Pharma Inc., we are revolutionizing healthcare through our Focus Area Approach. Our goal is to create innovative drugs and solutions to address high unmet medical needs, combining our cutting-edge expertise and knowledge with the latest technologies from external partners. We are dedicated to providing VALUE for patients by tackling the toughest challenges in over 70 countries around the world. Join us on the forefront of healthcare change and help us make a lasting impact on the future of medicine.