Berlin, August 1, 2024 – Bayer today announced that a New Drug Application (NDA) for the investigational compound elinzanetant has been submitted to the U.S. Food and Drug Administration (FDA) for the treatment of moderate to severe vasomotor symptoms (VMS, also known as hot flashes) associated with menopause.

柏林，2024年8月1日–拜耳今天宣布，研究化合物elinzanetant的新药申请（NDA）已提交给美国食品和药物管理局（FDA），用于治疗与更年期相关的中度至重度血管舒缩症状（VMS，也称为潮热）。

The submission is based on the positive results from the Phase III OASIS 1, 2 and 3 studies.“Half of the world’s population will experience menopause, with 27 million women in the U.S. currently experiencing this transition. Despite the impact menopausal symptoms may have on women’s health and quality of life, many go without treatment due to gaps in awareness, education, and limitations of treatment options available”, said Christine Roth, Executive Vice President, Global Product Strategy and Commercialization, Member of the Pharmaceutical Leadership Team at Bayer.

提交的材料基于第三阶段OASIS 1、2和3研究的积极结果。拜耳制药领导团队成员、全球产品战略和商业化执行副总裁克里斯汀·罗斯（ChristineRoth）表示：“世界上一半的人口将经历更年期，美国目前有2700万女性正在经历这一转变。尽管更年期症状可能会对女性的健康和生活质量产生影响，但由于意识、教育和可用治疗方案的局限性，许多人没有接受治疗。”

“The FDA submission for elinzanetant marks a significant milestone in our efforts to offer a new non-hormonal option for women. This further underscores our position as leaders in Women's Health and our dedication to addressing the unmet medical needs of women globally.”The submission is based on positive results from the OASIS 1, 2 and 3 Phase III studies evaluating the efficacy and safety of the investigational compound elinzanetant versus placebo.

“美国食品和药物管理局（FDA）提交的埃利扎尼坦（elinzanetant）是我们努力为女性提供新的非激素选择的一个重要里程碑。这进一步强调了我们作为女性健康领导者的地位，以及我们致力于解决全球女性未满足的医疗需求。”该提交是基于OASIS 1、2和3期III期研究的积极结果，该研究评估了研究化合物埃利扎尼坦与安慰剂的疗效和安全性。

Findings showed that elinzanetant (120 mg orally once daily) significantly reduced the frequency and severity of moderate-to-severe VMS and demonstrated a favorable safety profile with headache and fatigue being the most frequent treatment emergent adverse events (TEAEs) within the elinzanetant groups.

研究结果显示，依林扎尼坦（120 mg口服，每日一次）显着降低了中度至重度VMS的频率和严重程度，并显示出良好的安全性，头痛和疲劳是依林扎尼坦组中最常见的治疗紧急不良事件（TEAE）。

Consistent improvements were also seen across OASIS 1 and 2 in all three key secondary endpoints, with significant reduction in frequency of VMS at week 1, .

在所有三个关键的次要终点中，OASIS 1和2也取得了一致的改善，第1周的VM频率显着降低。