Voydeya: which risks did reviewers probe?

“results suggests that when anti-Nm antibody titers are low (i.e., prevaccination), CAP-mediated amplification is required to elicit effective SBA, and hence, there is an increased risk of danicopan promoting bacterial infections under these conditions.”

“Distribution studies in either pigmented rats or pigmented rabbits showed that danicopan crosses the blood-retina barrier, enters the neural retina (a tissue that does not contain melanin), and associates with ocular tissues containing melanin (e.g., uvea and choroid-retinal pigment epithelium) and with the skin in pigmented rats.”

“Multiple lines of evidence from the nonclinical data suggest that there is an increased risk of hepatobiliary liver injury associated with the administration of danicopan.”