AstraZeneca and FibroGens roxadustat, not yet filed in U.S., nabs 2nd anemia nod in China

FibroGen has not even filed its AstraZeneca-partnered oral anemia drug roxadustat for U.S. approval. But the collaborators have already scored their second nod for the blockbuster hopeful in China. Last December, the pair made a rare if not only case out of roxadustat by racking up its first-in-class approval in China before any other country. At that time, Chinese authorities greenlighted the drug for patients on dialysis. With this second approval, it’s now allowed to treat the larger nondialysis-dependent group. Assuming a green light across the chronic kidney disease population was close, SVB Leerink analyst Geoffrey Porges has projected roxadustat sales could reach $1 billion in China alone by 2025. The current approval is primarily based on a phase 3 trial that showed roxadustat could increase patients’ hemoglobin levels by a mean of 1.9 g/dL, compared with a reduction of 0.4 g/dL among patients on placebo. In a previous China-specific trial on dialysis-dependent patients, the drug produced a numerically greater hemoglobin improvement versus Johnson & Johnson and Amgen’s Epogen/Procrit. Because FibroGen was relocating its Chinese manufacturing site, the drugmakers couldn’t immediately launch roxadustat in China, and they’re still eyeing an official rollout later this year. But AstraZeneca has already been preparing for talks with the Chinese government to include roxadustat on the country��s National Reimbursement Drug List. Results of those talks are expected around the end of this year, Leon Wong, AstraZeneca’s EVP in charge of China and emerging markets told investors on a conference call in July.