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Bayer Reports the CHMP’s Positive Opinion of Elinzanetant to Treat Vasomotor Symptoms

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  • The CHMP has recommended elinzanetant for treating mod. to sev. vasomotor symptoms linked with menopause or caused by AET related to breast cancer based on P-III (OASIS-1, 2, 3 & 4) trials
  • OASIS-1 & 2 showed reduced mod. to sev. menopausal VMS vs. PBO at wks. 4 & 12, with >80% pts (incl. those who switched from PBO) achieved ≥50% VMS reduction by wk. 26, while meeting all 3 key 2EPs of reduced VMS frequency, improved sleep & QoL; published in The JAMA
  • OASIS-3 also depicted reduced mod. to sev. VMS vs. PBO over 12wks. with benefits maintained over 52wks. (published in The JAMA Internal Medicine), while OASIS-4 showed similar VMS, sleep, & QoL improvements in women on HR+ breast cancer endocrine therapy (published in The NEJM)

Ref: Bayer | Image: Bayer | Press Release

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