FibroGen’s anemia pill falls short in blood cancer study

05 May 2023
www.biopharmadive.com
Phase 3Clinical ResultDrug Approval
Dive Brief:
An anemia pill from FibroGen didn’t help patients with a type of bone marrow cancer stop receiving blood transfusions in a Phase 3 trial, the latest setback for a drug that approved internationally but rejected in the U.S.
The pill, roxadustat, is available in the European Union as Evrenzo and also in China, Korea and Japan to treat anemia associated with chronic kidney disease. However, the Food and Drug Administration spurned the medicine two years ago after a panel of outside advisers voted against its approval, citing safety risks.
The drug’s failure in myelodysplastic syndrome effectively ends clinical development in the U.S. for now, as FibroGen’s remaining active studies are focused in China and Europe. Wall Street analysts are zeroing in on another drug prospect FibroGenFibroGen is developing for patients with lung fibrosis and muscular dystrophy.
Dive Insight:
Biotechnology companies like FibroGen spent years developing the drugs in roxadustat’s class, which were once seen as more convenient, and potentially safer, medicines than the standard injectable therapies for anemia.
Yet safety issues have curtailed those expectations. FibroGen’s drug, as well as a similar medicine from Akebia Therapeutics, were turned back by the FDA. Only one of those treatments, GSK’s Jesduvroq, has passed muster with the agency, and it’s only available for chronic kidney disease patients on dialysis. It also has a safety warning citing the potential risk of blood clots and other cardiovasulcar problems.
FibroGen aimed to test another direction by studying roxadustat in myelodysplastic syndrome, a cancer-like condition of the bone marrow that often leads to anemia. The drug’s goal was to free people from the need for chronic blood transfusions in a Phase 3 trial known as MATTERHORN.
On Friday, FibroGen reported 47% of patients given roaxadustat in the study were able to stop transfusions in the first 28 weeks of treatment, compared with 33% of those receiving a placebo. The difference wasn’t statistically significant, FibroGen said.
FibroGen still sells roxadustat internationally. The company reported about $83 million in net revenue from roxadustat sales last year in China, where it co-promotes the drug with AstraZeneca. Partner Astellas, which markets the drug in Europe and Japan, reported sales of 3.2 billion yen, or about $24 million.
Investors and analysts are now focusing on the expected Phase 3 trial readout of another FibroGen drug, pamrevlumab, in the lung disease idiopathic pulmonary fibrosis. Results are expected around mid-year, along with data from a late-stage trial of the treatment in Duchenne muscular dystrophy.
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