AZ confirms cardiovascular safety with roxadustat results

pharmatimes | May 16, 2018

AstraZeneca has announced top-line results from the pooled cardiovascular (CV) safety analyses of its global Phase III roxadustat programme. 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. In the pooled analysis of around 4,000 dialysis-dependent patients, the MACE/MACE+ analyses between roxadustat and epoetin alfa showed no clinically-meaningful difference.

Spotlight

With complex development processes and stringent regulatory requirements, the path to developing a combination product can seem uncertain and fraught with risk. All elements of the delivery system must comply with the highest quality and regulatory standards.

Spotlight

With complex development processes and stringent regulatory requirements, the path to developing a combination product can seem uncertain and fraught with risk. All elements of the delivery system must comply with the highest quality and regulatory standards.

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