FibroGen's ($FGEN) in-development treatment for anemia is still in the midst of Phase III development, but thanks to a legal loophole, the pill has made its way into the world of competitive cycling, where its red blood cell-boosting effects can give athletes an advantage.
As The New York Times reports, FibroGen's drug can't be cleared for therapeutic use until the FDA weighs in on its safety and efficacy, but its chemical active ingredient, FG-4592, can be legally purchased for research purposes from suppliers around the world. Such companies require written confirmation that what they sell is for lab tests only, and they ship only to universities, but these precautions are apparently not enough to stem abuse.
The drug, developed as roxadustat by FibroGen and partner AstraZeneca ($AZN), is designed to mediate the transcription factors that control the amount of oxygen in cells, thereby spurring the body to naturally generate more red blood cells and thus battle the underlying cause of anemia.
Boosting blood oxygen is also tied to improving endurance and performance, which is useful for people without anemia who want to, say, win a bike race. So far, two high-profile cyclists have been accused of using FibroGen's drug to get an advantage, each awaiting confirmatory tests, according to the Times.
But any athletes obtaining roxadustat from chemical suppliers are putting themselves at serious risk, as such companies are not beholden to the strict--and strictly enforced--regulations for products designed for human use. Research-only agents are exactly that, manufactured for lab tests and animal trials rather than consumption by people.
Meanwhile, roxadustat is progressing through a sweeping global Phase III program, with AstraZeneca assisting in U.S. and Chinese development while Astellas holds the rights in Japan, Europe and the Middle East. FibroGen expects to submit the drug for approval in China next year and in the U.S. in 2018.
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