拜耳(BAYRY.US)first-in-class新药获批上市

Core Viewpoint - Bayer's elinzanetant has received approval from the UK's MHRA for the treatment of vasomotor symptoms (VMS) related to menopause, marking its first global approval for this indication [1][2] Group 1: Clinical Trials - Elinzanetant's approval is based on results from three Phase III clinical trials: OASIS-1, OASIS-2, and OASIS-3 [1] - OASIS-1 and OASIS-2 were double-blind, randomized, placebo-controlled studies involving 396 and 400 postmenopausal women aged 40-65 across 184 sites in 15 countries, assessing the drug's efficacy and safety over 26 weeks [1] - OASIS-3 was also a double-blind, randomized, placebo-controlled study, involving 628 postmenopausal women aged 40-65 across 83 sites in 9 countries, evaluating the drug's effects over 52 weeks [1] Group 2: Efficacy and Safety - Elinzanetant achieved all primary endpoints in the three studies, demonstrating good safety profiles [2] - In OASIS-1 and OASIS-2, elinzanetant significantly reduced the frequency and severity of VMS compared to placebo, with improvements in sleep disturbances and quality of life related to menopause [2] - OASIS-3 confirmed the results of OASIS-1 and OASIS-2, showing statistically significant reductions in VMS frequency from baseline to week 12, with sustained benefits and safety over 52 weeks [2] Group 3: Future Prospects - Bayer is continuing to pursue market applications for elinzanetant in the US, EU, and other global markets [2]