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Bayer AG

FDA Approves New Pill for Menopausal Women to Treat Hot Flashes and Night Sweats

Strategic Insights

— 1 min read

Menopause can be a challenging experience for women, with hot flashes and night sweats being two of the most common uncomfortable side effects. According to the National Menopause Foundation, up to 80 percent of menopausal women experience these symptoms. To combat this issue, the Food and Drug Administration (FDA) has approved a new pill called Elinzanetant, sold under the brand name Lynkuet, specifically designed to treat hot flashes and night sweats. Developed by drug manufacturer Bayer, Lynkuet blocks two kinds of brain receptors that affect temperature regulation, providing an alternative option for women who are either uncomfortable using hormone therapy or cannot use it due to medical reasons.

Key Takeaways:

  • The FDA has approved Lynkuet, a new pill for menopausal women to treat hot flashes and night sweats, in a moderate-to-severe state.
  • The drug blocks two kinds of brain receptors that affect temperature regulation.
  • Lynkuet has been shown to significantly reduce the frequency and severity of hot flashes and night sweats in three Phase III clinical trials.
  • The drug may also help with sleep issues, a common problem for menopausal women.
  • Common side effects of Lynkuet include headache, fatigue, and stomach pain.
  • The FDA approval comes after the drug was already approved in the United Kingdom, Australia, Canada, and Switzerland.
  • Bayer stated that Lynkuet is expected to be available in the U.S. by November and will cost $625 for a 30-day supply.

Statistics:

  • Up to 80 percent of menopausal women experience hot flashes and night sweats, according to the National Menopause Foundation.
  • Three Phase III clinical trials showed that Lynkuet significantly reduced the frequency and severity of hot flashes and night sweats.
  • Lynkuet may cause common side effects such as headache (X%), fatigue (X%), and stomach pain (X%).
  • The drug is expected to be available in the U.S. by November.
  • The cost of Lynkuet for a 30-day supply is $625.

Sources:

  • "The New York Times: Up to 80 percent of menopausal women experience hot flashes and night sweats." (Source: The New York Times)
  • "The National Menopause Foundation: Hot Flashes and Night Sweats." (Source: National Menopause Foundation)
  • "Bayer Press Release: FDA Approves First Non-Hormonal Pill for Hot Flashes and Night Sweats in Menopausal Women." (Source: Bayer)

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