1. Scrip
  2. >>Therapy Areas
  3. >>Genitourinary

First Approval For AZ's Roxadustat With China Green Light

 
• By Kevin Grogan

China is the first country to give the green light to roxadustat, AstraZeneca and FibroGen's first-in-class oral inhibitor of HIF-PHI, which could become standard of care to treat anemia in chronic kidney disease patients.

The Terracotta Army
China blazing a trail with roxadustat approval • Source: Shutterstock

AstraZeneca PLC's renal disease franchise has received a major boost with the news that partner FibroGen Inc. has bagged an approval for roxadustat to treat anemia in chronic kidney disease (CKD) patients on dialysis in China, the first country globally to approve the closely watched compound.

There is a lot of excitement surrounding roxadustat, which is a first-in-class oral inhibitor of hypoxia inducible factor-prolyl hydroxylase (HIF-PHI), as many observers believe it could replace erythropoietin stimulating agents (ESAs), notably Amgen Inc.'s Epogen (epoetin alfa) - and biosimilars thereof - as the standard of care because of an improved safety profile and the ability to eliminate the need for intravenous iron

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 Genitourinary

Still Looking For A Gene Therapy Hit, Syncona Backs Purespring In IgA Nephropathy Market

 
• By Andrew McConaghie

Purespring has just raised $105m from an investor syndicate who are betting it can develop the first gene therapy for kidney disease and learn from setbacks experienced in the space.

REGENCY Dandy for Roche In Lupus Nephritis

 
• By Elizabeth Cairns

Gazyva could add the autoimmune condition to its label following a Phase III hit, but it might struggle to differentiate itself from Benlysta and Lupkynis.    

AstraZeneca Believes Size Matters In Amyloidosis

 
• By Elizabeth Cairns

Following the pivotal data on Alnylam’s Amvuttra, all eyes turn to the next amyloidosis readout – that of AstraZeneca and Ionis’ Wainua. And the UK major’s ambitions do not stop there.    

Pfizer And Flagship’s Quotient To Seek Out New Heart And Kidney Drugs

 
• By Andrew McConaghie

The big pharma’s second selection in the alliance shows novel cardiovascular therapies are high on its priority list

More from Therapy Areas

‘Market Developments’ Persuade Galapagos To Rethink Spin-Off

 
• By Andrew McConaghie

CEO Paul Stoffels exits early to be succeeded by Henry Gosebruch, who will now consider ‘all options’ for the Belgian firm as it tries to claw back investor confidence.

Strong Showing For Bayer’s Pharma Business In Uncertain Times

 
• By Kevin Grogan

As CEO Anderson backs high prices for innovative drugs in Europe

Stock Watch: Stock Watch: Lilly And Novo Duke Out Q1

 
• By Andy Smith

Novo Nordisk enjoyed a surprise GLP-1 agonist contracting win in the first quarter of 2025. This provided a welcome boost to its stock after it had spent the previous quarter on the back foot against rival Lilly.