Shots:
- The EC has approved Lynkuet for the treatment of mod. to sev. vasomotor symptoms due to menopause or caused by adj. endocrine therapy related to breast cancer; regulatory filings are ongoing in other regions
- Approval was based on P-III (OASIS) program assessing Lynkuet (120mg, QD, PO), which consists of OASIS-1 (n=396), OASIS-2 (n=400) & OASIS-3 (n=628) in postmenopausal women (40-65yrs.) as well as OASIS-4 (n=474) in women with VMS due to endocrine therapy
- Lynkuet met all 1 & 2EPs in all 4 studies & showed favorable safety, with OASIS 1 & 2 data published in The JAMA, OASIS-3 in The JAMA Internal Medicine, & OASIS-4 in The NEJM
Ref: Bayer | Image: Bayer | Press Release
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