Fibrogen (FGEN) “believes” that its experimental anemia pill is safe. That’s nice, but on Thursday night, the San Francisco-based drug maker refused to disclose the actual data generated by a comprehensive examination of cardiac safety in thousands of patients enrolled in its clinical trials.
The safety data remain obscured, so Fibrogen’s wobbly assurances about the heart safety of its anemia pill are raising more questions than were answered.
Roxadustat is a potential blockbuster medicine, representing a new way to treat anemia suffered by kidney disease patients with a pill, instead of injections required by current treatments like Amgen’s Epogen. But roxadustat won’t be successful — it might never be approved — unless Fibrogen can convince regulators that the drug is not responsible for excess numbers of heart attacks, strokes, and other bad heart-related side effects.