FDA accepts elinzanetant NDA for vasomotor symptoms in menopause

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The FDA has accepted the New Drug Application for elinzanetant (Bayer) for the potential treatment of moderate-to-severe vasomotor symptoms (VMS) in menopause.¹ An expected target approval date has not been announced.

Elinzanetant is an investigational compound, that if approved, would make it the first dual neurokinin-1 and 3 (NK-1 and 3) receptor antagonist.¹

Supporting data

The application submission is supported by positive data from 2 clinical studies (OASIS 1, 2, and 3).¹

In OASIS 1 and 2, investigators studied the efficacy and safety of elinzanetant, which was administered orally, once daily in women with moderate to severe VMS associated with menopause across 26 weeks. The studies randomized 396 and 400 postmenopausal women between ages 40 and 65 years across 184 sites in 15 countries.¹

Patients who were randomized to the elinzanetant arm received a 120-mg dose of elinzanetant once daily for 26 weeks and patients randomized to the control arm received a matching placebo once daily for 12 weeks, followed by a 120-mg dose of elinzanetant for 14 weeks.¹

In OASIS 1 and 2, a reduction in VMS frequency and severity was reported among participants receiving elinzanetant. At week 4 and week 12, the mean frequency reductions were -3.29 and -3.22, respectively. These reductions were above the clinically relevant threshold of 2 VMS per day vs placebo. For severity, these reductions were -0.33 and -0.40, respectively.²

VMS symptoms at week 1, sleep disturbances, and menopause-related quality of life were all improved in patients taking elinzanetant vs placebo. A favorable safety profile was also reported, with side effects including headache and fatigue.²

In OASIS 3, investigators studied the efficacy and safety of elinzanetant for the treatment of VMS over 52 weeks in postmenopausal women. Patients enrolled included 628 postmenopausal women between the ages of 40 and 65 years across 83 sites in 9 countries. Treatment was administered orally once per day.³

In the elinzanetant group, a mean 1.6 moderate-to-severe VMS per day was recorded at week 12, vs 3.4 in the placebo group. This indicated a least-square mean difference of -1.6 VMS per day.³

For Patient-Reported Outcomes Measurement Information System Sleep Disturbance Short Form (PROMIS SD SF) scores, a mean change of -9.4 was reported from baseline to week 52 in the elinzanetant group vs -5.7 in the placebo group. Changes in Menopause-Specific Quality of Life (MENQOL) total scores were -1.3 and -1.1, respectively.³

In terms of safety outcomes, neither group reported a case of endometrial hyperplasia or malignant neoplasm. Additionally, BMD changes between baseline and week 52 were within expected age-related loss in both groups, and both groups maintained stable weight.³

"The good news was that [elinzanetant] we met its primary objective," Pinkerton said. "Hot flashes were significantly reduced at 12 weeks in this population of women who were not as severe as those in OASIS 1 and 2—more like you would see in your clinical practice—significantly reduced compared to placebo at 12 weeks, and then maintained that efficacy throughout the 52 weeks.”

Watch JoAnn Pinkerton, MD, FACOG, NCMP, discuss the latest elinzanetant data from the OASIS 3 trial below.

There is also a fourth phase 3 study underway (OASIS 4), which is investigating the efficacy and safety of elinzanetant in women with moderate to severe VMS caused by endocrine therapy for the treatment or prevention of breast cancer.¹

References:

1. U.S. Food and Drug Administration (FDA) accepts New Drug Application for elinzanetant. Bayer. October 9, 2024. Accessed October 9, 2024. https://www.bayer.com/media/en-us/us-food-and-drug-administration-fda-accepts-new-drug-application-for-elinzanetant/

2. Elinzanetant significantly reduces frequency and severity of moderate to severe hot flashes associated with menopause. Bayer. May 16, 2024. Accessed October 9, 2024. https://www.bayer.com/en/us/news-stories/elinzanetant

3. Panay N, Joffe H, Maki P, et al. Efficacy and long-term safety of elinzanetant for the treatment of VMS associated with menopause:A phase 3 randomized trial (OASIS 3). Presented at the 2024 Annual Meeting of The Menopause Society. Chicago, Illinois. September 10-14, 2024.