China first to approve AstraZeneca, FibroGen anaemia drug

LONDON (Reuters) – China has become the first country to approve a new anaemia drug from AstraZeneca and FibroGen, well before decisions by regulators in the United States or Europe.

Despite the early win, the two partners said on Tuesday they did not expect to launch roxadustat in China until the second half of 2019.

FibroGen sponsored the development and registration of roxadustat in China, while AstraZeneca is responsible for marketing the medicine. The companies had previously said they hoped for Chinese approval before the end of 2018.

The upcoming launch will help consolidate AstraZeneca’s position in China, where it has more than doubled sales since 2012. Today, China generates nearly a fifth of the drugmaker’s global revenue, a far higher proportion than for rivals.

Roxadustat is the first of a new kind of oral anaemia treatment called a hypoxia-inducible factor prolyl hydroxylase inhibitor that boosts production of red blood cells by mimicking the body’s response to high altitude.

The approval from China’s National Medical Products Administration clears its use in patients with anaemia caused by chronic kidney disease (CKD) who are on dialysis. Anaemia becomes increasingly common among individuals with CKD as the disease progresses.

The new pill is seen as a more convenient alternative to EPO, or erythropoietin, a class of injectable blood enhancers that have been under a cloud for some years due to cardiovascular safety concerns.