Astellas gets nod in Japan for roxadustat, ahead of GSK rival

Astellas has its first approval for roxadustat, getting a green light in Japan for the drug as a treatment for anaemia caused by chronic kidney disease (CKD).

Roxadustat is the first drug in the hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor class to be approved in Japan, beating its closest rival – daprodustat from GlaxoSmithKline/Kyowa Kirin – to the Japanese market. It will be sold under the Evrenzo brand name.

The orally active drug works in a different way to erythropoiesis-stimulating agents (ESAs) such as Kyowa Kirin’s Espo (epoetin alfa) and biosimilars, that are delivered by injection, and has been picked as a future blockbuster by Clarivate Analytics, with sales expected to approach $2 billion in 2023.

Roxadustat activates a red blood cell-generating response that occurs naturally when reduced oxygen levels are detected in the blood, and has been approved by Japan’s drug regulator for use in chronic kidney disease (CKD) patients whose disease is serious enough to require dialysis.

Astellas licensed rights to the drug in Japan from FibroGen, subsequently extending the deal to cover Europe, the Middle East, the Commonwealth of Independent States, and South Africa.

AstraZeneca has commercial rights to roxadustat in the rest of the world, including China where it was approved in December for use in CKD patients on dialysis and last month for non-dialysis-dependent patients, a much larger population.

So far, China and Japan are the only two countries to register roxadustat, and marketing applications are being prepared in Europe and the US.

In addition to the added convenience of oral dosing, HIF-PH inhibitors could also avoid some of the side effects linked to ESAs, including a higher risk of blood clots and tumours. They also don’t need to be kept in refrigerated storage unlike injectables.

Japan is thought to have a higher incidence of CKD than any other country, with 3.5 million people with anaemia related to the disease, and Astellas’ first-to-market advantage there could be critical.

GSK filed daprodustat in Japan last month, so Astellas will be able to build its brand for a year or so before its main rival could reach the market. If launched, GSK will be able tap into the established position held by Kyowa Kirin in marketing and distributing Espo in Japan.

CKD affects 1 in 10 people worldwide, and CKD anemia can severely worsen outcomes for patients, increasing the rate of progression to renal failure and the likelihood of cardiovascular complications. It also significantly reduces patients’ quality of life and their cognitive ability, says Astellas.