FibroGen (FGEN -0.76%) received some bad news recently with an overwhelmingly negative vote by a U.S. Food and Drug Administration (FDA) advisory committee related to anemia drug roxadustat. In this Motley Fool Live video recorded on July 19, 2021, healthcare and cannabis bureau chief Corinne Cardina and Motley Fool contributor Keith Speights discuss what's next for FibroGen after this disappointing vote.
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Corinne Cardina: Let's talk about the FDA. A little regulatory fun this Monday. We've talked about some FDA drama in the past months around Biogen (BIIB -0.84%) and the FDA Advisory Committee basically saying, "We don't like this Alzheimer's drug," and the FDA approved it anyway. That's an interesting background for this next topic.
Last week, an FDA Advisory Committee voted against approving AstraZeneca (AZN -0.68%) and FibroGen's anemia pill. It's called roxadustat. They were citing concerns about safety and other concerns including how the clinical trial demographics were made up, African Americans were underrepresented. FibroGen stock fell; AstraZeneca, which is a much bigger company, saw its stock tick down a little bit on this news. What are the top-line takeaways for what this FDA Advisory Committee decision means for healthcare investors?
Keith Speights: Yeah. Corinne, first of all, the FDA Advisory Committee voted 12 to 2 against recommending approval of roxadustat as a treatment of anemia due to chronic kidney disease in adult patients on dialysis. Then the Committee voted 13 to 1 against approval for the drug for patients not on dialysis.
The committee's concerns, there were several concerns actually, they had questions about cardiovascular safety, they had questions about the potential lack of quality-of-life improvements for the drug, as you mentioned, there were concerns that not enough African Americans were included in the clinical trials, so there could be underrepresentation there, they also were a little worried about FibroGen's planned postmarketing study of the drug.
There were several issues at play here that resulted in this really overwhelming vote against recommending this drug. This was almost certainly a huge blow to FibroGen's hopes for winning approval of the drug.
The FDA, of course, doesn't have to go along with the Advisory Committee's recommendation. As you mentioned, Biogen is a great example where the FDA did not go along with the committee's recommendation. In this case, though, I think it's pretty likely that the FDA is going to go along with exactly what the Ad Com is saying here, and they won't approve this drug in the United States.
Now, FibroGen has received good news outside of the U.S. The drug received a positive opinion from the European Committee for Medicinal Products for Human Use, and that positive opinion came in June.
Things look at least semi-good, look pretty good for getting approval in Europe. The drug has won regulatory approvals already in China and Japan, Chile, and South Korea, it's already on the market in some places; so it's not like FibroGen is going to be totally out of luck here.
But I think while this was bad news for FibroGen, of course, it was bad news for AstraZeneca, it was good news for companies that market other erythropoietin-stimulating drugs such as Amgen (AMGN 0.05%), is the notable one there; Amgen markets Epogen and Aranesp. That's good news for that company because it might not have a competitor on the scene in the U.S. market.
