GSK's Duvroq, Akebia's Vafseo win global first nods in Japan to challenge Astellas' anemia drug

Three next-gen anemia drugs have all arrived, thanks to two simultaneous global first approvals in Japan.

Monday, GlaxoSmithKline’s Kyowa Kirin-partnered Duvroq and Akebia Therapeutics’ Mitsubishi Tanabe-paired Vafseo both earned blessings from Japanese drug regulators to treat anemia due to chronic kidney disease.

The two meds can now take on the first-to-market Evrenzo, from FibroGen and local collaborator Astellas, in a three-way rumble for share. It's a fight set to move far beyond Japan as the trio—the first oral drugs in the field—rack up approvals around the world.

Both of the latest approvals cover patients regardless of their dialysis status, and they follow a green light for Evrenzo (roxadustat) in the more severe dialysis population in September 2019. In January, Astellas filed a follow-up application, hoping to add the larger nondialysis approval to its label.

By GSK's estimate, around 3.5 million patients in Japan suffer from anemia associated with renal disease.

All three drugs belong to the hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) class, which mimics an oxygen deprivation environment in the body to encourage bone marrow to make more red blood cells to combat anemia. As oral drugs, they boast a convenience advantage over traditional erythropoietin-stimulating injections from Amgen and Johnson & Johnson.

GSK’s Duvroq approval is based on data from three Japan-specific studies. One pitted Duvroq (daprodustat) against Amgen’s Aranesp in dialysis patients while another compared the new med with experimental epoetin beta pegol in nondialysis CKD patients.

Both showed Duvroq worked as well at increasing hemoglobin levels as the widely used treatments did. A third small open-label trial used Duvroq in all 28 dialysis patients who hadn’t received erythropoietin agents before.

To support its U.S. and EU nods, GSK is running two global phase 3 programs. The Ascend-D trial in dialysis patients has completed enrollment while the Ascend-ND study is still recruiting nondialysis patients.

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In May, Akebia said results from two global phase 3 trial showed Vafseo (vadadustat) matched up to Aranesp in improving hemoglobin in patients on dialysis. Readout from the nondialysis trial is expected soon. They'll form the basis for an application at the FDA. Akebia has teamed up with Otsuka on major markets outside of Japan.

Chronic kidney disease-related anemia represents a blockbuster field. EvaluatePharma previously predicted first-to-market roxadustat could hit $1.49 billion in 2024 sales.

AstraZeneca first won approval for roxadustat in China in 2018, and the British drugmaker is also responsible for U.S. commercialization, as Astellas helps FibroGen in Japan and Europe. The FDA is slated to rule on FibroGen’s application for roxadustat in both dialysis-dependent and non-dialysis patients by Dec. 20.

Duvroq and Vafseo witnessed a busy day at Japan’s Ministry of Health, Labour and Welfare. Besides the two anemia therapies, the agency on Monday also waved through Roche’s neuromyelitis optica spectrum disorder therapy Enspryng (satralizumab), a competitor to Alexion’s Soliris.

Meanwhile, Novartis saw five simultaneous approvals in Japan on the same day, for MET inhibitor Tabrecta for MET exon 14 skipping non-small cell lung cancer; for Entresto in chronic heart failure; for Mayzent in secondary progressive multiple sclerosis; and for Enerzair and Atectura in different forms of asthma.