Vifor Pharma and Akebia Therapeutics amend vadadustat license agreement

The Vifor Pharma Group and Akebia Therapeutics signed an agreement in 2017 granting Vifor Pharma a license to sell vadadustat, an investigational oral hypoxia-inducible factor prolyl hydroxylase inhibitor, to Fresenius Medical Care North America for use solely within its dialysis clinics in the U.S., subject to FDA approval.
Vadadustat is currently in phase-III development for the treatment of anaemia due to chronic kidney disease, and this license agreement has now been amended, subject to FDA approval, to permit Vifor Pharma to sell vadadustat to certain third-party dialysis organisations as well, again for use in the U.S. The license will also be subject to vadadustat’s inclusion in the Centres for Medicare & Medicaid End Stage Renal Disease Prospective Payment System (ESRD PPS), and will be effective during the Transitional Drug Add-on Payment Adjustment two-year period that is expected to precede the ESRD bundle period.
President of the Executive Committee and COO at Vifor Pharma, Stefan Schulze, said “We are very pleased to have amended our license agreement with Akebia. We believe that vadadustat has the potential to play an important role in the future treatment of anaemia due to CKD and we will work closely with our strategic partner Fresenius Medical Care to maximise this opportunity.”
John P. Butler, President and Chief Executive Officer of Akebia Therapeutics, Inc., said: “We believe the expansion of this agreement reflects enthusiasm about our development program and the potential for vadadustat to treat anaemia due to CKD. We are excited to be building on our relationship with Vifor Pharma to facilitate access to vadadustat to a larger group of dialysis patients, subject to its approval by the FDA.”