Medical News Hubb
Advertisement
  • Home
  • News
  • Pharmaceutical
  • Medicines & Healthy Lifestyle
  • Contact us
No Result
View All Result
  • Home
  • News
  • Pharmaceutical
  • Medicines & Healthy Lifestyle
  • Contact us
No Result
View All Result
Medical News Hubb
No Result
View All Result
Home Medicines & Healthy Lifestyle

Fezolinetant NDA Accepted for Vasomotor Symptoms With Menopause

admin by admin
August 19, 2022
in Medicines & Healthy Lifestyle


The Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for fezolinetant, an investigational, nonhormonal selective neurokinin-3 receptor (NK3R) antagonist for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause.

Fezolinetant works by inhibiting neurokinin B binding on the kisspeptin/neurokinin/dynorphin neuron to regulate neuronal activity in the thermoregulatory center in the hypothalamus. The NDA is supported by the BRIGHT SKY program, which included efficacy and safety data from the pivotal phase 3 SKYLIGHT 1 (ClinicalTrials.gov: NCT04003155) and 2 (ClinicalTrials.gov: NCT04003142), along with the SKYLIGHT 4 safety study (ClinicalTrials.gov: NCT04003389). 

The randomized, double-blind, placebo-controlled SKYLIGHT 1 and 2 studies evaluated the efficacy and safety of fezolinetant 30mg and 45mg orally once daily in 1028 women aged 40 to 65 years with moderate to severe VMS. The first 12 weeks of the trials were double-blinded and placebo-controlled, and were followed by 40-week active treatment extension periods.


Continue Reading

Findings from both trials showed that both doses of fezolinetant met all 4 co-primary end points achieving statistically significant reductions in the frequency and severity of moderate to severe VMS at week 4 and week 12 from baseline compared with placebo. The most common treatment emergent adverse event for fezolinetant was headache. The incidence of serious TEAEs was reported to be less than 2% in patients treated with fezolinetant.

A Prescription Drug User Fee Act target action date of February 22, 2023 has been set for this application.

“The FDA’s acceptance of our NDA for fezolinetant brings us one step closer to advancing care for women in the US who experience VMS,” said Ahsan Arozullah, MD, MPH, Senior Vice President and Head of Development Therapeutic Areas, Astellas. “We look forward to the FDA’s review of our application, and the potential to offer a first-in-class nonhormonal treatment option to reduce the frequency and severity of moderate to severe VMS associated with menopause.”

References

  1. U.S. FDA accepts Astellas’ New Drug Application for fezolinetant. News release. Astellas Pharma Inc. Accessed August 18, 2022. https://www.prnewswire.com/news-releases/us-fda-accepts-astellas-new-drug-application-for-fezolinetant-301608116.html
  2. Astellas to present 12-week data from pivotal phase 3 SKYLIGHT 1™ trial of fezolinetant in oral session at the American College of Obstetricians and Gynecologists Annual Meeting. News release. Astellas Pharma Inc. May 6, 2022. Accessed August 18, 2022. https://www.astellas.com/en/news/25781
  3. Astellas to present fezolinetant 12-week findings from phase 3 SKYLIGHT 2™ Trial in oral session at The North American Menopause Society 2021 Annual Meeting. September 22, 2021. Accessed August 18, 2022. https://www.astellas.com/en/news/17176

This article originally appeared on MPR

Topics:

Obstetrics and Gynecology
Women’s Health



Source link

Previous Post

Think You Avoided Omicron? Think Again. Here’s Why You May Have Been Infected

Next Post

Health Bulletin 19/August/2022

Next Post

Health Bulletin 19/August/2022

Recommended

Health Bulletin 17/January/2023

January 17, 2023

Polio Virus Found in NYC Sewer System

August 14, 2022

Don't miss it

Pharmaceutical

AbbVie to lift $2B deal cap as Humira rivals appear

February 6, 2023
Medicines & Healthy Lifestyle

Trial Investigating Pembrolizumab for Hormone-Sensitive Prostate Cancer Discontinued

February 6, 2023
Medicines & Healthy Lifestyle

Low Sex Drive Can Be Treated By Hormone Injections, Study Shows

February 6, 2023
News

USTR Seeks Public Comment on Restoring Tariffs on Chinese Medical Products

February 6, 2023
Pharmaceutical

Health Bulletin 6/ February/ 2023

February 6, 2023
Pharmaceutical

FDA: Base blood donation policy on science, not stigma

February 5, 2023

© 2022 Medical News Hubb All rights reserved.

Use of these names, logos, and brands does not imply endorsement unless specified. By using this site, you agree to the Privacy Policy and Terms & Conditions.

Navigate Site

  • Home
  • News
  • Pharmaceutical
  • Medicines & Healthy Lifestyle
  • Contact us

Newsletter Sign Up

No Result
View All Result
  • Home
  • News
  • Pharmaceutical
  • Medicines & Healthy Lifestyle
  • Contact us

© 2022 Medical News Hubb All rights reserved.