- FibroGen is cutting jobs and restructuring as it struggles to get an anemia pill back on track in the U.S. after a major regulatory blow.
- The Food and Drug Administration rejected roxadustat in August, indicating Fibrogen needed more clinical study on the drug's safety. On Tuesday, FibroGen said it and partner AstraZeneca are scheduled to meet with the FDA soon to see if there's a viable path forward.
- The restructuring, meanwhile, will save FibroGen $100 million annually for the next three years, according to a Nov. 9 statement. The company laid off about 30 employees in the U.S. and won't fill about 70 previously open positions. About 600 employees globally were employed by the company as of Jan. 31, 2021.
The upcoming FDA meeting is critical for FibroGen. CEO Enrique Conterno told analysts on a conference call this week that he believes the company has a "good proposal" for moving forward with roxadustat, but declined to speculate on what might happen to the AstraZeneca partnership.
AstraZeneca may be open to paying for more clinical research, but much depends on the extent of the FDA requirements and the potential label for the drug, SVB Leerink analyst Geoffrey Porges wrote in a note to investors. The companies would want to have a label that helps them compete with rivals in the future, particularly a drug being developed by GlaxoSmithKline, he said.
One path the companies will explore is approval for a lower starting dose of roxadustat and a different dosing strategy, FibroGen Chief Medical Officer Mark Eisner told analysts. The company also raised that possibility at an FDA advisory committee before the rejection, but panel members said a new regimen would need to be tested in patients before it could be approved.
FibroGen already has won approval for roxadustat in the European Union and major markets including China and Japan for patients with anemia associated with chronic kidney disease. It's part of a new class of drugs that block a protein called hypoxia inducible factor prolyl hydroxylase, or HIF-PH, and help prompt the body to make red blood cells.
The company isn't the only biotech to lay off employees this fall. Theravance Biopharma and Esperion cut substantial portions of their workforces in September and October, respectively, amid broader company reorganizations.