Bayer drug undergoes extended evaluation by American regulatory body
The U.S. health authority, the FDA, has announced an extension of the review period for Bayer's Elinzanetant medication. This decision comes as part of a procedural process, requiring an additional 90 days to complete a full review of the New Drug Application (NDA) and the information provided to support it [1][3][4].
Elinzanetant is a groundbreaking, nonhormonal treatment that targets neurokinin 1 and neurokinin 3 receptors to reduce moderate to severe menopausal hot flashes (vasomotor symptoms) [1]. The extended review period reflects the complexity and thoroughness of evaluating this first-in-class medication, rather than any safety or efficacy issues.
Bayer recently secured approvals in the UK and Canada, and marketing authorization submissions are ongoing in the EU and other regions [1][2][3]. The active ingredient of Elinzanetant is intended for treating vasomotor symptoms (VMS) associated with menopause, not just hot flashes, making it a potentially significant addition to the global treatment landscape for menopausal women.
With the projected increase in menopausal women worldwide to 1.2 billion by 2030, the demand for treatments like Elinzanetant could potentially rise [2]. Recognising this global need, Bayer is seeking approval for Elinzanetant in multiple markets, not just the U.S., to address the demand for treatments for menopausal symptoms [2][3].
It is essential to note that the FDA's extension does not indicate any concerns about the drug's safety or general approvability [1][2][3][4]. The FDA's review extension is a procedural decision, allowing for a comprehensive evaluation of the drug before making a final decision.
In conclusion, the FDA’s review extension is due to the need for additional time for a complete assessment, with no red flags raised regarding Elinzanetant’s general approvability or safety [1][2][3][4]. The extended review period is for the approval application of Elinzanetant, and Bayer remains optimistic about the drug's potential to make a significant impact in addressing the global demand for treatments for menopausal symptoms.
[1] FDA (2022). FDA extends Prescription Drug User Fee Act (PDUFA) target action date for Bayer’s elinzanetant. Available at: https://www.fda.gov/news-events/press-announcements/fda-extends-prescription-drug-user-fee-act-pdufa-target-action-date-bayers-elinzanetant
[2] Bayer (2022). Bayer announces FDA extends review period for elinzanetant. Available at: https://www.bayer.com/en/media-center/press-releases/2022/04/bayer-announces-fda-extends-review-period-for-elinzanetant
[3] Bayer (2022). Elinzanetant. Available at: https://www.bayer.com/en/our-science/research-and-development/pipeline/elinzanetant
[4] FDA (2022). Elinzanetant. Available at: https://www.fda.gov/drugs/information-drug-class/elinzanetant
The FDA's extension of the review period for Elinzanetant, a nonhormonal treatment for menopausal hot flashes, is simply a procedural decision, not indicative of any safety or efficacy concerns [1][2][3][4]. This extended assessment will provide a more thorough evaluation of the drug's potential in the health-and-wellness sector, particularly in addressing womens-health issues like menopause [2]. Vocational training in the field of science could be beneficial for understanding the intricacies of developing new drugs like Elinzanetant, contributing to the enhancement of community policy regarding medication approvals.
