FibroGen admitted erring in how it has been evaluating roxadustat’s Phase III data, with the correct analysis taking some of the shine off the agent’s safety profile. Investors are now asking grave questions about the regulatory and commercial prospects for it and perhaps other oral hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitors that were once expected to revolutionise the chronic kidney disease (CKD) arena.
To provide FirstWord readers with rapid feedback on what the news means for roxadustat and other HIF-PH inhibitors, we are hosting an expert call with a key opinion leader (KOL) next week.
Key topics that will be discussed during the call include, among other things… how concerned are you by this week’s admission from FibroGen; how significant is it that roxadustat can no longer claim superiority to erythropoietin-stimulating agents (ESAs) in dialysis-dependent (DD) patients; does this update hurt roxadustat’s odds of approval; how, if at all, does it affect your thoughts on roxadustat; will it make physicians less likely to prescribe roxadustat to DD patients; will this have any impact on its use in non-dialysis-dependent (NDD) patients; could this update affect whether roxadustat ends up with a black box warning on its label; how important is the presence or absence of a black box warning; might the change in roxadustat’s risk/benefit profile have any impact on other HIF-PH inhibitors; does the FibroGen news help or hurt competing HIF-PH inhibitors; and which from this class do you expect to prescribe the most, and why?
Ask the expert!
Furthermore, we invite FirstWord Pharma readers to submit their own questions for consideration. Please click here to do so. We can't guarantee that all questions submitted will be asked due to time constraints, but we will do our utmost to cover the important issues relating to the use of oral HIF-PH inhibitor to treat anaemia in CKD.
We endeavour to provide feedback from KOLs as quickly as possible. Interview content will be published for FirstWord Pharma PLUS subscribers to read. To be notified when the interview content is available please click here.
As always, FirstWord Pharma would very much like to receive your feedback and suggestions.
To read more KOL Views articles, click here.