Akebia Proposes Updated Dosing For Oral Anemia Drug Vadadustat

After an FDA rejection and a failed collaboration, Akebia Therapeutics is continuing to pursue a market for its oral anemia medicine, vadadustat. The company has now presented the first evidence for a lower dose regimen at the same time it is appealing the FDA’s decision.

Dialysis patients with anemia caused by long-term renal disease found that vadadustat, administered three times weekly, was equally effective as the erythropoiesis-stimulating agent (ESA) Mircera, developed by Roche and CSL Vifor.

Akebia announced that the FO2CUS study had been successful in its third phase. The business claims that over two measurement windows, vadadustat performed similarly to Mircera at two separate dosing levels.

Vadadustat, a once-daily medication used to treat anemia caused by chronic renal disease, is now commercially available in Japan. Mitsubishi Tanabe Pharma, a local partner of Akebia, received this approval in 2020 and has been marketing the drug as Vafseo since then. After receiving support from EMA drug reviewers, the European Commission is anticipated to shortly issue a go-ahead for patients reliant on dialysis.

Clinical studies conducted in support of those applications evaluated vadadustat as a once-daily medication with a maximum recommended dosage of 600 milligrams (mg). Akebia proposes two dose strengths for the FO2CUS study: 600 mg and 900 mg, each taken three times weekly.

Akebia R&D head Steven Burke said in a statement released on Monday that the decreased dose frequency is significant since it coincides with patients’ dialysis appointments and, if authorized, may give an oral alternate to the standard of care.

Hemoglobin levels decreased by 0.43 g/dL on average in dialysis patients who received 600 mg of vadadustat throughout weeks 20 and 26 of the primary endpoint follow-up. The 900 mg group, meanwhile, saw their levels drop by an average of 0.23 g/dL.

Akebia did not reveal how the control group fared, simply that the gap between vadadustat and Mircera fell within the 0.75 g/dL noninferiority limit.

The positive readout comes as Akebia fights with the FDA over a complete response letter the agency handed out to vadadustat in March 2022. The FDA voiced worries at the time that the drug posed hazards to the heart and liver.

Akebia thinks the benefit-risk profile of vadadustat is favorable, at least in patients requiring dialysis due to their advanced renal disease. In October, the company filed a formal complaint to dispute the FDA’s decision in the dialysis group.

This week, Akebia provided an update in which it stated that it had a constructive discussion with the FDA’s Office of New Drugs Director, Peter Stein, M.D., who is overseeing the issue. According to Akebia, Stein is in consultation with agency specialists in a process that might be completed by June, and he hopes to respond to the appeal by thirty days after that.

The company’s initial application is at issue; hence, FO2CUS’s updated data is immaterial. Top-line results suggest that the safety profiles were consistent amongst treatments, according to Akebia; however, the company did not include extensive evaluations of cardiovascular or liver safety in its Monday announcement.

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