Vafseo Chronology: Complete Response Letter, Dispute Resolution And A Second-Cycle Approval

The Pink Sheet’s Drug Review Profile looks at the timeline behind the development and US FDA approval of Akebia’s Vafseo, a treatment for anemia in chronic kidney disease patients on dialysis.

Drug Review Profile: Vafseo Chronology
Valadustat needed almost 15 years for to move from IND submission to NDA approval. • Source: Shutterstock

The US regulatory history of Akebia Therapeutics, Inc.’s Vafseo (vadadustat) featured a complete response letter, a denied formal dispute resolution request, and a race with two other drugs in the same novel class that were pursuing a broad indication for treatment of anemia in chronic kidney disease patients.

Ultimately, vadadustat earned the second CRL, and the second approval, of the three oral hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitors...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet 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 Drug Review Profiles

Potency Assay Issues Delayed US FDA Approval Of Mesoblast’s Ryoncil For Years

 
• By 

The company’s failure to show its potency assays measured attributes directly related to the mesenchymal stromal cell product’s therapeutic effect highlights the importance of a robust CMC program for complex cell therapies.

Mesoblast’s Ryoncil: US FDA Changed Its Mind On Need For A Randomized Trial

 
• By 

Agency staff repeatedly said the BLA based on a single-arm study in 55 patients lacked substantial evidence of effectiveness in steroid-refractory acute graft-versus-host disease and a randomized trial was needed, but changed course “based on additional consideration” after a second CRL.

Ryoncil Chronology: Three Review Cycles, Two CRLs, One Dispute Resolution Request

 
• By 

The Pink Sheet’s Drug Review Profile looks at the timeline for the clinical development and US FDA review of Mesoblast’s remestemcel for graft-versus-host disease.

Testosterone, TRAVERSE, And A Label Change 15 Years In The Making

 

The Pink Sheet drug review profile investigates the long and rigorous process behind the FDA’s recent relaxation of the cardiovascular safety warning for testosterone products.

More from Product Reviews