One of the key CV safety endpoints is major adverse CV events (defined as MACE), and another key CV safety endpoint evaluated MACE plus heart failure requiring hospitalisation and unstable angina requiring hospitalisation (defined as MACE+).
The first-in-class hypoxia-inducible-factor prolyl hydroxylase inhibitor (HIF-PHI) was evaluated in three separate tests:
In the pooled analysis of over 4,300 patients of MACE/MACE+ in non-dialysis-dependent patients, based on the totality of the adjudicated evidence, the MACE/MACE+ analyses between roxadustat and placebo showed no clinically-meaningful difference.
In the pool of 1,500 incident (newly-initiated) dialysis patients, MACE/MACE+ results indicate that incident dialysis patients on roxadustat do better than those who are on epoetin alfa.
Mene Pangalos, executive vice president, R&D BioPharmaceuticals, said: “We are pleased to report these data from the largest clinical programme in the world evaluating this new class of medicines.
These results add to the growing body of positive evidence to support roxadustat for the treatment of anaemia in chronic kidney disease patients, following our announcement that the primary efficacy endpoints were met for the OLYMPUS and ROCKIES trials in December 2018. There is a significant unmet medical need among patients living with chronic kidney disease, and we look forward to working with FibroGen to prepare for regulatory submissions of roxadustat.”
The companies will begin discussions with the US Food and Drug Administration (FDA) to prepare for regulatory submission, which is anticipated in the second half of 2019.