FibroGen and AstraZeneca have ended their oral anemia drug development and commercialization collaboration in the U.S. and other regions outside of China.
The partnership, which began back in 2013, allowed AstraZeneca to lead the development and commercialization efforts of roxadustat outside of China. Roxadustat is an oral medication that treats CKD-related anemia by promoting red blood cell production. It is approved in several jurisdictions, including China, Europe and Japan, for the treatment of anemia in CKD patients, whether they are undergoing dialysis or not. The drug works by enhancing the body's production of erythropoietin, improving iron absorption, and reducing hepcidin levels, a liver-produced hormone that regulates iron metabolism by controlling the absorption and distribution of iron in the body.
Despite holding promise, roxadustat’s regulatory journey in the U.S. has been anything but easy. In 2021, FibroGen faced backlash after revealing it had modified data in a study on roxadustat. The company acknowledged making retrospective adjustments to phase 3 trial data affecting patient subgroup stratifications, which initially suggested the drug posed lower cardiovascular risks compared to existing treatments. However, revised analyses indicated that the drug did not offer a safety advantage for new dialysis patients, undermining one of its key benefits.
A few months later, the FDA’s advisory committee voted against the drug's approval. In August 2021, FibroGen was handed a complete response letter from the agency, asking for another study of the drug if the company wanted to apply for approval again.
Now, under the new termination agreement, AstraZeneca will return all rights for roxadustat to FibroGen, with the exception of South Korea, and will assist during the transition period. Their collaboration in China, where roxadustat is a leading treatment for anemia associated with chronic kidney disease, remains unaffected.
