Bayer has announced that the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK has granted approval for elinzanetant, marketed as Lynkuet.
This marks the first global approval for the dual neurokinin-targeted therapy, designed to treat moderate to severe vasomotor symptoms (VMS), commonly referred to as hot flashes, associated with menopause.
Bayer pharmaceuticals leadership team member and global product strategy and commercialisation executive vice president Christine Roth said: “This first approval worldwide marks a significant milestone for our hormone-free treatment elinzanetant to manage some of the most disruptive menopausal symptoms.
“It highlights Bayer’s longstanding commitment to advance women’s health, and we are looking forward to bringing this option to many more women around the world.”
The approval is based on successful results from the Phase III OASIS-1, -2, and -3 studies, which evaluated the drug’s efficacy and safety.
The OASIS-1 and -2 trials demonstrated that elinzanetant significantly reduced the frequency and severity of VMS compared to a placebo at weeks 4 and 12. By week 26, over 80% of participants on elinzanetant experienced at least a 50% reduction in VMS frequency.
These studies also showed improvements in sleep disturbances and menopause-related quality of life. OASIS-3 further confirmed these findings, showing sustained benefits and a favourable safety profile over 52 weeks, with common side effects including headache, fatigue, and somnolence.
Elinzanetant is the first treatment targeting both NK-1 and NK-3 receptors, addressing VMS through its impact on hypothalamic neurons involved in thermoregulation. The drug is administered orally once daily. Bayer is pursuing regulatory approval for elinzanetant in the US, EU, and other international markets, following the positive outcomes of the Phase III trials.
In a separate development, Bayer has submitted a marketing authorisation application to the European Medicines Agency for gadoquatrane, an investigational contrast agent for magnetic resonance imaging (MRI).
The agent aims to enhance contrast in MRI scans to detect pathologies across all body regions and the central nervous system in both adults and children, including neonates.
If approved, gadoquatrane will offer a 60% reduction in gadolinium dose compared to current macrocyclic contrast agents, potentially making it the lowest dose available in the EU.
