Bayer receives first approval for Lynkuet in UK as treatment for vasomotor symptoms associated with menopause
The UK authorization is based on positive results from the Phase III OASIS-1, -2, and -3 trials
The UK authorization is based on positive results from the Phase III OASIS-1, -2, and -3 trials
Effective, holistic, science-backed targeted solutions for symptomatic treatment
The New Drug Application (NDA) includes data from the Phase III studies OASIS 1, 2 and 3 - showing elinzanetant significantly reduced the frequency and severity of moderate to severe vasomotor symptoms over 12 weeks compared to placebo
Sleep disturbances are among the most frequent and disruptive symptoms associated with menopause which can impact women’s health and quality of life
Pivotal OASIS 1 and 2 Phase III studies of investigational compound elinzanetant achieved a statistically significant reduction in frequency and severity of vasomotor symptoms
VEOZAH is first-in-class treatment option to reduce the frequency and severity of moderate to severe VMS due to menopause
Regulatory filings underway for a third indication for darolutamide in prostate cancer, for finerenone in a common form of heart failure, and acoramidis in transthyretin amyloid
The study also met all secondary endpoints with a reduction in severity of VMS at weeks 4 and 12, a reduction in frequency of VMS at week 1 as well as improvements in sleep disturbances and menopause related quality of life
Pharmaceuticals and Consumer Health report higher sales (Fx & portfolio adj.) and lower earnings
The approved product has an estimated market size of US$ 268 million for the twelve months ending June 2024, according to IQVIA
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