The US Food and Drug Administration (FDA) has approved a treatment for menopause relief, bringing the country in line with Britain, Australia, Canada and Switzerland, where regulators gave the green light for Bayer’s non-hormonal medication earlier this year.
The Independent reports that the drug, called Elinzanetant and sold under the brand name Lynkuet, is recommended for moderate-to-severe vasomotor symptoms (hot flushes and night sweats).
“The approval of Lynkuet is an important new option for women and providers treating these menopause symptoms,” said Dr Yesmean Wahdan, Bayer’s head of medical affairs in the US and North America.
The drug was approved in the United Kingdom by the Medicines and Healthcare products Regulatory Agency in July, making it the first regulator in the world to do so.
The FDA approval comes after three phase 3 clinical trials, which showed that Lynkuet significantly reduced the frequency and severity of hot flushes and night sweats, and may also help with sleep issues.
Bayer said the drug is expected to be available in America by November.
See more from MedicalBrief archives:
Non-hormonal pill eases menopause symptoms, study finds
Bayer seeks approval for ‘hot flushes’ drug