Following FDA rejection, AstraZeneca finally gives up US rights to roxadustat

AstraZeneca and FibroGen have concluded their collaboration on the oral anemia medication roxadustat in the United States after a series of setbacks. This decision follows more than two years since the FDA’s rejection of the drug, leading AstraZeneca to relinquish its rights to roxadustat in the U.S. and certain other regions. However, the company still maintains interests in China and South Korea, where the drug is marketed as Evrenzo.

The recent announcement comes after roxadustat’s phase 3 trial failure in anemia patients with myelodysplastic syndromes (MDS), which occurred approximately 10 months ago. This setback marked a significant blow to roxadustat’s prospects in the U.S. market, following the FDA’s rejection in 2021 for its use in anemia associated with chronic kidney disease. Despite these challenges, FibroGen remains optimistic about roxadustat’s potential in other applications.

Initially hailed as a groundbreaking medication, roxadustat epitomized the unfulfilled expectations of the HIF-PH inhibitor drug class. While initially believed to offer advantages in convenience and safety over standard treatments, FibroGen later acknowledged manipulation in the phase 3 trial analysis, which misrepresented the drug’s efficacy. Subsequent FDA reviews revealed additional safety concerns, including heightened risks of mortality, blood clots, and infections.

Following the FDA’s complete response letter, FibroGen and AstraZeneca failed to reach an agreement on a new trial plan, hindering roxadustat’s path to reevaluation. Similar outcomes befell Akebia Therapeutics’ vadadustat in 2022. However, the HIF-PH inhibitor class received its inaugural FDA approval with GSK’s daprodustat in early 2023, marking a milestone for the drug category.

While Evrenzo secured approval in several countries outside the U.S., its commercial performance has been largely lackluster, except in China. Notably, sales in China have experienced robust growth, reaching $284 million in 2023 through a joint venture between AstraZeneca and FibroGen. Despite a price reduction due to changes in insurance coverage, FibroGen anticipates continued growth in Evrenzo’s sales in China, driven by potential approvals for additional indications.

In the United States, FibroGen remains hopeful about roxadustat’s prospects, particularly in addressing unmet needs such as anemia associated with MDS. Despite previous trial failures, the company’s CEO expressed optimism based on favorable outcomes in specific patient subsets.

As attention shifts away from roxadustat, FibroGen investors are turning their focus to the company’s lead candidate, pamrevlumab. FibroGen anticipates phase 3 trial results from the LAPIS trial for pamrevlumab in locally advanced pancreatic cancer, alongside evaluation in the Precision Promise trial for metastatic pancreatic cancer.

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