1. Scrip
  2. >>R&D
  3. >>Clinical Trials

Astellas’s Long-Term Safety Data Could Boost Fezolinetant’s Approval Chances

 
• By Joseph Haas

With a pair of successful Phase III pivotal studies in hand, the Japanese pharma reports that its nonhormonal hot flash/night sweats candidate demonstrated safety and tolerability over 52 weeks.

hot flash VMS
Astellas hopes to bring a nonhormonal therapy for hot flashes to market • Source: Alamy

Astellas Pharma, Inc. has already conducted two successful pivotal trials to support upcoming regulatory filings for fezolinetant, its nonhormonal drug candidate for menopause vasomotor symptoms (VMS) like hot flashes and night sweats. But new findings announced 7 March provide additional long-term safety data in a field where safety has been a particular issue, and innovation is needed.

Fezolinetant is a once-daily, oral neurokinin 3 (NK3) receptor antagonist, which acts upon specific neurons that control body temperature to mimic the effects of estrogen. It could provide a novel, nonhormonal alternative to the standard-of-care hormonal therapies that may be associated with increased risks of breast cancer and venous thromboembolic events

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Scrip for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Clinical Trials

Pipeline Watch: Six Approvals And Thirteen Phase III Readouts

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.

Viatris Will File ‘Fast-Acting’ Meloxicam For FDA Approval This Year

 
• By Joseph Haas

Seven years after acquiring it, Viatris will seek approval of a meloxicam formulation for acute pain backed by data from two Phase III studies in post-surgical pain settings.

CRISPR Therapeutics Unveils Promising Early In Vivo Cholesterol-Lowering Results

 
• By Andrew McConaghie

The Phase I results are the best to date among ANGPTL3-targeting candidates in the pipeline, but analysts will wait for further updates before predicting a likely winner.

Sanofi R&D Head’s Words Of Wisdom For Biotechs

 
• By Kevin Grogan

Houman Ashrafian tells delegates at Swiss Biotech Day that ‘literally only two things matter in our industry – target credentialing and differentiated pharmacology. The rest is execution.’

More from R&D

Sanofi R&D Head’s Words Of Wisdom For Biotechs

 
• By Kevin Grogan

Houman Ashrafian tells delegates at Swiss Biotech Day that ‘literally only two things matter in our industry – target credentialing and differentiated pharmacology. The rest is execution.’

Marea Eyes Cardioprotective Benefit With ANGPTL4 Inhibition

 
• By Joseph Haas

Phase IIa data for ANGPTL4-targeted antibody shows reduced triglycerides and remnant cholesterol, which Marea asserts indicates potential to protect against cardiovascular outcomes.

First Win For AstraZeneca’s Enhertu In Early-Stage Breast Cancer Treatment

 
• By Andrew McConaghie

Already dominating in later lines of breast cancer treatment, Enhertu could now displace both chemotherapy combinations and Roche’s Kadcyla in early-stage HER2-positive patients.