After string of setbacks, FibroGen and AstraZeneca's anemia drug Evrenzo finally chalks up a win

After an FDA rejection, commercial disappointments in Europe and Japan and a clinical trial flop, FibroGen and AstraZeneca’s oral anemia drug Evrenzo has finally found a win back in China.

In a phase 3 trial in China, Evrenzo matched up to 3SBio’s recombinant erythropoietin alfa injection, Sepo, when used to treat anemia in cancer patients receiving chemotherapy, FibroGen said Thursday.

Evrenzo, also known as roxadustat, was as effective as Sepo at restoring patients’ hemoglobin levels to normal during weeks 9 to 13 of the study, the company said.

As for safety, the drug’s side effect profile was “generally consistent with previous findings and supportive of a positive benefit risk in this patient population,” FibroGen said.

FibroGen said it will work with AZ to file an application with Chinese authorities. The two companies’ partnership around Evrenzo started back in 2013.

Chemo-induced anemia represents a large market in China. More than 3 million cancer patients undergo chemotherapy in China each year, and up to 80% can develop anemia, according to FibroGen.

3SBio’s Epiao and Sepo held 44.5% market share among recombinant human erythropoietin products in China in 2022, according to the Chinese company’s annual report. Together, the two 3SBio therapies generated 1.13 billion Chinese yuan ($160 million) last year.

In late 2018, Chinese regulators were the first to approve Evrenzo, making the medicine the first in the HIF-PHI class to gain approval anywhere. The drug won its first approval to treat chronic kidney disease patients on dialysis and later added the non-dialysis patient population to its label.

In the first quarter, Evrenzo generated $64.1 million in China, up from $43.5 million during the same period in 2022.

But safety signals disrupted FibroGen and AZ’s plan for U.S. approval in CKD patients in 2021. And a phase 3 failure earlier this month in myelodysplastic syndromes essentially dashed the companies’ remaining hopes for the drug’s entry into the U.S. market.

Meanwhile, in Japan and Europe, FibroGen’s partner Astellas just booked an impairment charge worth 47 billion Japanese yen ($348 million) for Evrenzo based on gloomy sales projections.

With a U.S. approval for Evrenzo out of the picture, FibroGen investors are focused on the company’s wholly owned pamrevlumab, William Blair analyst Andy Hsieh, Ph.D., said in a note last week.

An inhibitor of the connective tissue growth factor, pamrevlumab is currently undergoing phase 3 trials in idiopathic pulmonary fibrosis (IPF), locally advanced pancreatic cancer, and Duchenne muscular dystrophy (DMD). Two DMD trials and an IPF study are expected to read out this year, and topline data from a second IPF study and the pancreatic cancer trial could come out in 2024.