Akebia Therapeutics
NEWS
Akebia Therapeutics on Thursday said it regained full U.S. rights to its chronic kidney disease anemia drug Vafseo, which the biotech has priced at around $15,500 per year.
After an initial rejection due to safety issues, followed by a dispute and deferred actions, Akebia Therapeutics on Wednesday finally won the FDA’s nod for vadadustat as a treatment for anemia caused by chronic kidney disease.
The FDA will close out a hectic month of March with a flurry of target action dates, including ones for lymphoma and CKD anemia treatments.
Akebia announced it will submit a new NDA targeting CKD patients on dialysis, which will not involve additional trials.
Akebia Therapeutics announced another delay Tuesday in a series of setbacks for vadadustat, being developed to treat anemia linked to chronic kidney disease.
Akebia Therapeutics has submitted a Formal Dispute Resolution Request with the FDA regarding the rejection of vadadustat in anemia due to chronic kidney disease.
This week, drugs developed by Neurocrine Biosciences, Akebia, Eliem and Athira all failed to meet expectations in clinical trials.
Otsuka Pharmaceutical terminated a deal with Akebia Therapeutics, which ends the U.S. and ex-U.S. vadadustat Collaboration and License Agreements.
Akebia Therapeutics’s partner Otsuka Pharmaceutical Co. announced plans to terminate its global license agreements with Akebia for vadadustat.
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