If approved, elinzanetant would be another non-hormonal option for menopausal women seeking hot flash relief.
Bayer announced today that the FDA has accepted their new drug application (NDA) for menopause drug, elinzanetant, to treat moderate to severe menopausal vasomotor symptoms, according to details published in a news release. Elinzanetant is the first dual neurokinin-1 and 3 (NK-1 and 3) receptor antagonist in late development for menopause relief. The Prescription Drug User Fee Act (PDUFA) date is July 26, 2025, according to a Bayer representative.
Elinzanetant is a once daily 120 mg pill formulated to treat vasomotor symptoms, also known as hot flashes. During menopause, decreased estrogen levels cause the body’s “thermostat,” or hypothalamus to become extra sensitive. When the hypothalamus thinks the body is too warm, it starts a chain reaction in the form of a hot flash to cool the body down. Elinzanetant decreases hot flashes by modulating estrogen sensitive neurons in the hypothalamus.
The NDA acceptance is based on positive data from three phase 3 OASIS studies, which demonstrated efficacy. Hot flash frequency and severity was measured using an electronic hot flash diary.
OASIS 1 and 2 studied the effects of elinzanetant in nearly 400 women ages 40 to 65 over 26 weeks across 15 countries. By week 4, 62.8% of participants in OASIS 1 and 62.2% of participants in OASIS 2 reported a decrease in hot flash severity. Full results were published in JAMA Network in August.
OASIS 3 extended the treatment window to 52 weeks. Details were presented at The Menopause Society Annual Meeting last month.
OASIS 4 is an expansion of the phase three program and will investigate the efficacy of elinzanetant for women experiencing hot flashes because of endocrine therapy or breast cancer prevention, not menopause.
“If approved, elinzanetant will offer a new non-hormonal option to women seeking treatment for moderate to severe vasomotor symptoms and we look forward to the review by the agency," Christine Roth, executive vice president of Global Product Strategy and Commercialization and member of the Pharmaceutical Leadership Team at Bayer, said in the news release.
In addition to the OASIS trials, Bayer is conducting NIRVANA, a phase 2, double blind study exploring the use of elinzanetant to treat sleep disturbances associated with menopause. Approximately 69% of women experience sleep disturbances during menopause. Difficulty falling or staying asleep can be attributed to hot flashes or changes in mood, specifically depression.
About 47 million women enter menopause every year. Up to 80% of menopausal women report having hot flashes which are one of the top medical concerns for women during this period. Severe symptoms can last up to 10 years after a woman’s last menstrual cycle.
FDA Advisory Committee Votes Down Sotagliflozin in Type 1 Diabetes and CKD
November 1st 2024Committee members said there was uncertainty around sotagliflozin in patients with kidney disease. The FDA is currently reviewing the oral therapy as an adjunct to insulin to help control glycemic levels in adults with type 1 diabetes and chronic kidney disease. The agency’s goal date is Dec. 20, 2024.
Read More
ICER Gives Cell Therapy for Post-Transplant Complications High Rating
Published: October 31st 2024 | Updated: October 31st 2024ICER has given tabelecleucel a rating of A, indicating the T cell therapy for Epstein-Barr virus related post-transplant lymphoproliferative disease has a high certainty of substantial net health benefit and would be cost-effective if priced between $143,900 and $273,700.
Read More