Overview

• The MHRA has become the first regulator worldwide to approve Bayer’s elinzanetant for private prescription to treat moderate to severe menopausal hot flushes.
• Elinzanetant provides a non-hormonal alternative to hormone replacement therapy by targeting overactive brain signals triggered by declining oestrogen to regulate body temperature.
• Phase III Oasis trials in over 1,400 women showed up to a 65% drop in hot flush frequency at 12 weeks and more than 80% of participants achieved at least a 50% reduction by week 26 with improved sleep quality.
• The medicine met MHRA standards for safety, quality and effectiveness, was well tolerated in clinical studies and will undergo ongoing post-marketing surveillance.
• A forthcoming NICE appraisal will assess the pill’s cost-effectiveness and determine whether it will be adopted and reimbursed by the NHS.