Bayer gets UK approval for Lynkuet for menopause symptoms

Bayer has announced that the Medicines and Healthcare products Regulatory Agency (MHRA, regulatory authority in the UK) has authorized the use of elinzanetant, the first dual neurokinin NK)-targeted therapy (NK-1 and NK-3 receptor antagonist) under the brand name Lynkuet™ (Lynkuet^®* in UK) for the treatment of moderate to severe vasomotor symptoms (VMS, also known as hot flashes) associated with menopause in the United Kingdom.

“Menopausal symptoms, such as hot flashes, can have a profound impact on the quality of life for women. They are not just physical discomforts; they can significantly disrupt daily activities, sleep and emotional well-being,” said Dr Paula Briggs, Consultant Gynaecologist in Sexual and Reproductive Health in Liverpool Women’s NHS Foundation Trust, Immediate Past Chair of the British Menopause Society. “I welcome expanded therapeutic options that address the diverse needs and preferences of women going through menopause. Physicians now have a new hormone-free treatment option that offers an alternative for tailoring treatment plans, helping women manage their symptoms and potentially enhance their overall quality of life during this important transition,” said Christine Roth, Executive Vice President, Global Product Strategy and Commercialization and Member of the Pharmaceuticals Leadership Team at Bayer.

The marketing authorization in the UK is the first approval worldwide and based on positive results from the Phase III studies OASIS-1, -2 and -3 evaluating the efficacy and safety profile of elinzanetant. Elinzanetant met all primary endpoints in all three studies and demonstrated a favorable safety profile.

In OASIS-1 and -2, elinzanetant significantly reduced mean frequency and severity of moderate to severe VMS associated with menopause compared to placebo at weeks 4 and 12. Efficacy was maintained with over 80% of participants in the elinzanetant group achieving at least a 50% reduction in VMS frequency by week 26, including those who switched from placebo to elinzanetant after week 12. Both trials also achieved all three key secondary endpoints showing a statistically significant mean reduction in the frequency of VMS from baseline to week 1, as well as statistically significant improvements in sleep disturbances and menopause-related quality of life compared to placebo.

In OASIS-3, elinzanetant demonstrated a statistically significant mean reduction in the frequency of moderate to severe VMS from baseline to week 12 compared to placebo. The VMS reductions were maintained throughout the study duration. OASIS-3 reinforced the findings from OASIS-1 and -2, reporting a sustained benefit and safety profile over 52 weeks with the most frequently reported adverse with elinzanetant versus placebo being headache, fatigue and somnolence (also known as drowsiness).

www.bayer.com