FDA Committee votes against AstraZeneca anaemia treatment

The FDA’s Cardiovascular and Renal Drugs Advisory Committee voted 13 to 1 that the benefit-risk profile of the drug does not support approval for the treatment of anaemia in chronic kidney disease in NDD adults, and 12 to 2 in DD adults.

AstraZeneca said the FDA will consider the vote, independent opinions and recommendations from experts as it reviews the new drug application (NDA) but noted that it is not bound by the Committee's recommendation.

Mene Pangalos, executive vice president of BioPharmaceuticals R&D at AstraZeneca, said: "New solutions are needed for the six million people in the US affected by anaemia of chronic kidney disease.

"Although we are disappointed by today's outcome, we will continue to work closely with our partner FibroGen and the FDA to determine the path forward for roxadustat."

Broker Shore Capital said it’s not uncommon to see the regulator follow the advice of advisory committees and as such it does not expect roxadustat to be approved in the US at this stage based on existing data.

Analyst Adam Barker said: "We are not surprised by this decision, following FibroGen’s (AstraZeneca’s partner for this drug) update in April in which the safety profile of roxadustat became less compelling on updated data.

"Specifically, in the NDD population we always had concerns that the FDA would deem that the drug could slightly elevate the risk of cardiovascular events. In this case, we didn’t see a market opportunity given existing drugs aren’t used in this population due to concerns over cardiovascular risk.

"In the DD population, the key consideration was what benefit roxadustat offered over existing drugs (specifically, epoetin-alfa) and the updated data from FibroGen did not suggest a statistically significant improvement on cardiovascular outcomes.

"Given existing biosimilars would likely be cheaper than roxadustat, without a compelling benefit, it didn’t seem like there was a large opportunity in this group either."