Bayer Ready To File Elinzanetant After It Clears Third Phase III Hurdle

Will Compete With Sluggish Astellas Competitor

Bayer will submit its non-hormonal treatment for vasomotor symptoms associated with menopause for approvals this year, still eyeing €1bn-plus in peak sales despite a rival’s slow start.

Tired, stressed mature business woman suffering from neck pain, working from home office, sitting at table
Elinzanetant reduces hot flashes and may improve sleep in menopausal women • Source: Shutterstock

Bayer AG reported positive topline results from the third and final Phase III clinical trial of its non-hormonal treatment for vasomotor symptoms (VMS) associated with menopause on 19 March, declaring that it will now seek approvals for elinzanetant in multiple markets. This will pit the drug against a rival product, Astellas Pharma, Inc.’s Veozah (fezolinetant), which to date has seen sluggish sales that prompted the Japanese drug maker to lower its forecast for the product.

Key Takeaways
  • Bayer reported topline results from the third, final and longest Phase III trial of elinzanetant and plans to seek approvals later this year with launches expected in 2025.

  • Detailed data remain under wraps, but the company is confident that its drug – a crucial future revenue driver – has a better profile than Astellas’s competing approved drug Veozah

Bayer has maintained its forecast that elinzanetant, a dual antagonist of the neurokinin 1 and 3 (NK-1,3) receptors, will achieve €1bn-plus in peak sales despite the slow uptake of Astellas’s drug, an NK-3 antagonist

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

More from Clinical Trials

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

 
• By 

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 

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

 

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.

In Brief: Strong OS Results For Immutep’s Eftilagimod/Keytruda Combo In Head And Neck Cancer

 

Australian firm's combo of eftilagimod and Keytruda shows 17.6-month median overall survival in first-line HNSCC patients with low PD-L1, raising hopes for potential accelerated approval.

More from R&D

In Brief: Positive New Data For Aptose’s Triplet Therapy In 1L AML

 

Aptose’s tuspetinib triplet shows early mutation-agnostic promise in new data from Phase I/II program for frontline acute myeloid leukemia.

Chinese Firms Build Obesity Clinical Pipeline But Face Wider Hurdles

 
• By 

Despite the ability to initiate clinical trials quickly and having strong manufacturing capacity, Chinese companies are facing multiple challenges in the obesity space.

Aldeyra Plans To File Reproxalap Again With New Dry Eye Symptom Data

 
• By 

The biotech hopes a third time will be the charm after two FDA complete responses, with plans to position its eye drop as offering quicker onset of action.