First Approval For AZ's Roxadustat With China Green Light
China is the first country to give the green light to roxadustat, AstraZeneca and FibroGen's first-in-class oral inhibitor of HIF-PHI, which could become standard of care to treat anemia in chronic kidney disease patients.
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Touted in China after its first approval globally there for chronic kidney disease-associated anemia back in late 2018, FibroGen/AstraZeneca's roxadustat has now been rejected by the US FDA over cardiovascular safety concerns. But ex-US markets may still enable the drug to shine despite safety wording.
Astellas becomes first to market in Japan in new class of oral anemia drugs, beating multiple rivals in a sector set to see strong growth but also fierce competition.
AstraZeneca, Novartis and Roche deliver north of 20% sales growth in China again, driven by expanded reimbursement coverage and new product launches, but some clouds are on the horizon over falling sales due to the impact of the expanding “4+7” centralized procurement scheme.