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

Phase III Roxadustat ALPS Data Positive For New Class Of Anemia Therapies

 
• By John Davis

Positive top-line data from the ALPS study confirms the efficacy and safety of roxadustat, a Phase III-stage product which could be the first a new class of orally active agents with potential in the treatment of anemia associated with chronic kidney disease.  

Kidneys
• Source: Shutterstock

Japan's Astellas Pharma Inc. has announced positive top-line data from the ALPS Phase III study involving the use of the oral investigational agent, roxadustat, in patients with chronic kidney disease (CKD) and anemia not on dialysis, boding well for its use as a therapeutic option in the condition, and for its potential to displace the use of erythropoietin.

The ALPS study found roxadustat showed superiority in efficacy versus placebo in terms of hemoglobin (Hb) response rate in the...

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

Capricor Gets Complete Response For DMD Cell Therapy

 
• By Joseph Haas

Seven weeks before its action date, Capricor got an FDA complete response for cell therapy deramiocel in DMD-related cardiomyopathy. It has a Phase III study nearing readout, though.

Bayer Bags First Global Okay For Hot Flashes Therapy

 
• By Kevin Grogan

Lynkuet will compete with Astellas's Veozah/Veoza

Glenmark Chief On IGI’s Landmark Trispecific Deal: Strong Data Excited AbbVie

 
• By Anju Ghangurde

Glenmark’s managing director talks about IGI’s billion dollar-plus deal with AbbVie, ISB-2001’s striking data, the BEAT platform, other "exciting" pipeline assets and the "blood, sweat and tears" to get to this stage.

Four Chinese Firms Snag Global First-In-Class Approvals In China

 
• By Dexter Jie Yan

Four Chinese companies have won approvals in China, the first anywhere, for novel drugs for diffuse large B-cell lymphoma, certain types of non-small cell lung cancer and influenza A.

More from R&D

Ultragenyx and Mereo Still Confident Despite Setrusumab Slip Up

 
• By Kevin Grogan

The osteogenesis imperfecta drug stumbled in a second interim analysis.

Investors Back Nuclidium’s Next-Gen Copper-Based Radiopharmaceuticals

 
• By Andrew McConaghie

The Swiss company believes its platform can make radiopharmaceuticals easier to produce and more accessible to patients.

Lupin’s Cimzia Biosimilar Candidate Reflects Strategy To Separate Wheat From Chaff

 
• By Vibha Ravi

Lupin's choice of a Cimzia biosimilar candidate and partnering with Zentiva reflect a strategy to sort the wheat from the chaff. Of 118 biologics to lose patent protection between 2025 and 2034 as per IQVIA, it’s going for a biosimilar with a single competitor though there could be other spoilers