After US Woes, Akebia Celebrates EU Nod For Vafseo

Recommended For Anemia Associated With Kidney Disease

The US biotech is in the throes of an appeal to the FDA against the rejection of its HIF-PH inhibitor but regulators in the EU have looked more kindly on vadadustat, which will be sold as Vafseo.

Human kidney on scientific background. 3d illustration
• Source: Shutterstock

While Akebia Therapeutics, Inc.'s appeal against the US Food and Drug Administration's rejection last March of vadadustat drags on, the company has received a thumbs-up for the kidney disease therapy in the EU.

More from New Products

Boehringer Still Sees Plenty Of Juice In Jardiance

 
• By 

Strong sales growth for the German group’s SGLT2 inhibitor in 2024

Pipeline Watch: Seventeen Approvals And Ten 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.

Sanofi Set To Shake Up Crowded Hemophilia Space After Qfitlia Approval

 
• By 

The small interference RNA therapeutic can be used by patients regardless of inhibitor status.

Unicycive Approaches Its First Approval, But In A Competitive Space

 

The company is planning to launch oxylanthanum carbonate for chronic kidney disease patients on dialysis with hyperphosphatemia.

More from Scrip

Axsome Plans Excessive Sleepiness Study In Depression After Phase III Failure

 

The study’s failure in the overall MDD population was not a surprise, but solriamfetol’s efficacy in MDD with EDS provided a rationale for testing it in that subpopulation.

Will They Or Won’t They? Tariff Question Looms For Drugmakers

 

Pharma executives and investors are waiting with bated breath to find out if President Trump will include drugs in a new round of tariffs to be announced on 2 April.

Cerevance To Focus On Parkinson’s Adjunctive Therapy After Phase II Miss

 
• By 

After failing a Phase II monotherapy study in early Parkinson’s, Cerevance will focus on adjunctive therapy without abandoning the monotherapy concept.