Akebia Therapeutics has suffered yet another major setback in the development of vadadustat, a drug designed to treat anemia caused by chronic kidney disease. This marks yet another delay in the much-anticipated launch of the drug.
The FDA has issued a second interim response to Akebia’s appeal for vadadustat, with the determination now assigned to Peter Stein, M.D., director of the Office of New Drugs. The news sent shockwaves through the markets, sending Akebia’s stock plummeting 9% in pre-market trading.
Dr. Stein announced that he would take further measures to determine the outcome of the appeal, by consulting with nephrology, cardiology and liver safety experts from the OND. This means that the final decision will take even longer to be reached.
Vadadustat is an innovative oral medication, designed to mimic the effect of living at high altitudes by increasing oxygen availability. This is achieved through its ability to inhibit the Hypoxia-Inducible Factor Prolyl Hydroxylase, a key enzyme responsible for regulating oxygen levels in the body. By taking Vadadustat, you can enjoy the benefits of living at high altitude without ever leaving the ground!
Akebia has taken a major step towards providing relief to those suffering from anemia in Chronic Kidney Disease (CKD), as the drug has passed the critical Phase III clinical trials. The company has now submitted a New Drug Application to the U.S. Food and Drug Administration (FDA) for final approval, setting the stage for a potential breakthrough in treating anemia.
In March 2022, the FDA made a shocking decision to reject a proposed treatment for CKD-linked anemia, citing safety concerns. This came as a surprise to many, as the treatment had been touted as a potential breakthrough for those suffering from this debilitating condition. Nevertheless, the FDA’s decision was firm and demonstrated their commitment to upholding the highest standards of safety for medical treatments.
The FDA has raised concerns about the safety of vadadustat, noting potential risks such as thromboembolic events and drug-induced liver injury. Despite data provided, the agency has determined that the benefit-risk assessment of vadadustat for dialysis and non-dialysis patients is unfavorable.
In November 2022, Akebia took the bold step of submitting a Formal Dispute Resolution Request to the FDA. The regulator responded with an interim response one month later, requesting additional information to further explore Akebia’s appeal. It was a bold move, but one that could prove to be the difference-maker in their case.
In September 2020, Akebia released the results of their Phase III clinical trial for vadadustat, a treatment for adult patients with chronic kidney disease (CKD) who are not on dialysis. Unfortunately, the trial failed to meet multiple safety endpoints.
Akebia and its former partner, Otsuka Pharmaceuticals, have made a major breakthrough in the medical industry with the development of Vadadustat, an approved therapy for dialysis and non-dialysis-dependent patients in Japan. This revolutionary treatment could be a game changer for those living with chronic kidney disease.