Akebia receives European approval for anemia drug
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Key takeaways:
- Akebia Therapeutics received approval by the European Commission to market its anemia drug Vafseo (vadadustat).
- The oral hypoxia-inducible factor prolyl hydroxylase inhibitor is now approved in 32 countries.
Akebia Therapeutics Inc. has received approval from the European Commission to market its oral hypoxia-inducible factor prolyl hydroxylase inhibitor Vafseo in Europe, according to a press release.
Vafseo (vadadustat) was approved as a once-a-day treatment for anemia in adults on chronic maintenance dialysis. The approval is applicable to all 27 European Union member states and Iceland, Norway and Liechtenstein, according to the release. Vadadustat is now approved for use to treat anemia in 32 countries.
"We're extremely pleased the [European Commission] EC has approved Vafseo, an important milestone for Akebia but even more impactful for the hundreds of thousands of Europeans diagnosed with anemia associated with [chronic kidney disease] CKD on dialysis," John P. Butler, CEO of Akebia, said in the release. "We believe patients receiving chronic maintenance dialysis would benefit from additional therapeutic options.”
The oral hypoxia-inducible factor prolyl hydroxylase inhibitor was approved in 150 mg, 300 mg and 450 mg tablets by the EC.
The approval of Vafseo follows the European Medicines Agency's Committee for Medicinal Products for Human Use positive opinion issued in February recommending the EC approve the drug.
The approval is based on data from the INNO2VATE phase 3 trial, a development program that included more than 7,500 adults on dialysis treated for anemia, according to the release.
Vadadustat achieved the primary and key secondary efficacy endpoints in each of the two INNO2VATE studies, demonstrating noninferiority to darbepoetin alfa as measured by a mean change in hemoglobin between baseline and the primary evaluation period (weeks 24 to 36) and secondary evaluation period (weeks 40 to 52), according to the release.
Vadadustat also achieved the primary safety endpoint of the INNO2VATE program, defined as noninferiority of Vadadustat vs. darbepoetin alfa in time to first occurrence of major adverse cardiovascular events.
Vadadustat has been approved for use in Japan as a treatment for anemia due to CKD in both dialysis-dependent and non-dialysis dependent adults.
Reference:
- Akebia receives European Commission approval for Vafseo (vadadustat) for the treatment of symptomatic anemia associated with chronic kidney disease in adults on chronic maintenance dialysis.https://ir.akebia.com/news-releases/news-release-details/akebia-receives-european-commission-approval-vafseotm-vadadustat. Published April 25, 2023. Accessed April 27, 2023.
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