For the first time, China’s medicines regulator has approved a new drug from a multinational company before regulators in the U.S. or EU.
The drug, roxadustat, is a hypoxia-inducible prolyl hydroxylase inhibitor that is indicated to treat anemia in patients with chronic kidney disease that are on dialysis.
AstraZeneca will market the drug, but it was developed as a collaboration with FibroGen, a San Francisco-based biopharma company that specializes in anemia, fibrosis and cancer treatments.
The approval in China comes as the country takes calculated steps to grow its pharma industry and more quickly bring innovative treatments to market. According to the Wall Street Journal, China has already approved 30 new drugs this year and is expected to pass the 40 mark it hit in 2017 (which was the most the new drug approvals in China in about 10 years).
To speed approval in China, the companies were awarded priority review and were allowed to submit trial information on a rolling basis, rather than waiting until all of the key clinical data was collected.
The companies have not submitted their application for roxadustat to the FDA yet, but plan to next year. They will also wait to launch the drug in China until 2019.
Read the full Wall Street Journal report.
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