CBI member, AstraZeneca has reported that China’s National Medical Products Administration has approved the used of Roxadustat in China for the treatment of anaemia caused by chronic kidney disease in non-dialysis dependent patients.
China has become the first country to approve Roxadustat for all chronic kidney patients with anaemia.
This authorisation follows the approval of AstraZeneca’s Roxadustat treatment plan in China in December 2018 for anaemia in chronic kidney disease patients who are on dialysis.
Following approval, AstraZeneca expect to launch the drug and make it available to non-dialysis dependent patients during the second half of 2019.
Mene Panglos, AstraZeneca, Executive Vice-President, Bio-Pharmaceuticals said: “With this approval for Roxadustat in China, [AstraZeneca] are now able to provide first in class medicine to all patients living with chronic kidney disease who may experience anaemia, regardless of whether they require dialysis. This is a significant milestone and we look forward to bring the medicine to patients later this year.”
The approval is primarily supported by Phase III trials in non-dialysis dependent patients with anaemia, in which Roxadustat demonstrated a statistically significant improvement in haemoglobin levels.
Anaemia commonly develops in association with chronic kidney disease in both the dialysis and non-dialysis dependent patients. In China, chronic kidney disease affects an estimated 120 million patients. Although chronic kidney disease may occur at any age, it is more common in aging populations, and its prevalence is increasing. Chronic kidney disease can be both a cause and a consequence of cardiovascular disease and is a critical healthcare issue. There is no treatment available that is curative or has the ability to stop kidney deterioration.
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