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Menopause: Bayer Files First Application for Elinzanetant

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Menopause affects millions of women worldwide, and vasomotor symptoms (VMS) such as hot flushes are a common complaint. Bayer has filed for the Food and Drug Administration (FDA) approval for elinzanetant, an oral neurokinin (NK) 1 and 3 antagonist, as a non-hormonal treatment for moderate to severe VMS associated with menopause. This new treatment option, if approved, will be the first direct competition to Astellas’ NK 3 antagonist Veozah (fezolinetant), which was approved by the FDA last year and is available in 14 countries.
Both elinzanetant and Veozah offer alternatives to hormone replacement therapy (HRT), which can be effective but is not recommended for some women due to the risk of stroke, heart attack, or certain cancers. Elinzanetant has shown significant reductions in the frequency and severity of VMS in phase 3 trials, positioning it as a promising new option for women seeking non-hormonal treatments.

Menopause Drug Market Sees Surge as Astellas Reports Strong Sales for Veozah

Astellas has reported strong financial performance for Veozah, with sales increasing more than tenfold in the first three months of the current fiscal year compared to the same period last year. This suggests growing momentum and market acceptance for NK-acting drugs. Analysts believe that having a second NK-acting drug in the market could raise awareness and drive uptake of both products.

The market potential for these treatments is substantial, with approximately 27 million women in the US currently experiencing menopause and the global number expected to reach 1.2 billion by 2030. Up to 80% of women report experiencing VMS during menopause, and around one-third suffer from severe symptoms that can last for many years.

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That is in part due to other potential benefits – like improved mental and potentially cognitive health – as well as research suggesting the risk of side effects like breast cancer is lower than previously thought, particularly with newer formulations.

Menopause

Menopause Treatment Options Needed, Says Bayer’s Christine Roth, Despite HRT’s Resurgence

Christine Roth, head of global product strategy and commercialization at Bayer, highlighted the need for more treatment options, noting that many women go without treatment due to gaps in awareness and limitations of available therapies. While HRT remains widely available and relatively inexpensive, it has seen a resurgence in popularity due to research suggesting lower risks of side effects with newer formulations.

Bayer is also conducting a fourth phase 3 trial of elinzanetant to evaluate its effectiveness in treating VMS associated with endocrine therapy for breast cancer. This trial, along with the growing interest in non-hormonal treatments for menopausal symptoms, underscores the potential for elinzanetant to become a significant player in the market.

Bayer meanwhile recently started a fourth phase 3 trial of elinzanetant that will test the drug’s ability to treat VMS associated with endocrine therapy of breast cancer. GlobalData recently predicted Astellas’ therapy will make $1.8 billion in 2030, thanks to its first-to-market advantage, with elinzanetant making $1 billion in the same year.

 

Resource: Bayer, August 1, 2024

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