Pharmaceutical giant AstraZeneca said on Tuesday that the Food and Drug Administration will convene a meeting of its Cardiovascular and Renal Drugs Advisory Committee to review a new US drug application for Roxadustat.
Roxadustat, AstraZeneca’s collaborative effort with American firm FibroGen, has been under regulatory review for the treatment of anaemia of chronic kidney disease, with the meeting following a move by the FDA in December to extend the review period in order to carry out further analysis of data.
The drug has already been approved to treat anaemia in chronic kidney disease in non-dialysis dependent and dialysis-dependent adults patients in China, Japan and Chile and is also under regulatory review in the EU.
As of 0850 GMT, AstraZeneca shares were down 0.64% at 6,935.0p.
