AZ confirms cardiovascular safety with roxadustat results

pharmatimes | May 16, 2018

AZ confirms cardiovascular safety with roxadustat results
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

In the European Union (EU), where strained healthcare systems are facing ever greater demands from an ageing population, generic medicines have played a significant part in controlling costs. Off-patent medicines now account for 92% of the treatment volume in the region. And competition from generic medicines drives the cost of off-patent products down61% from their cost during market exclusivity. This saved payers an estimated €100Bn in 2014 and has contributed to significantly higher access for patients in many countries, across many therapeutic areas. However, over the next several years, the number of small molecule original brands losing their market exclusivity in Europe and the savings opportunities to be had from generic medicines and the competition they create will be dramatically reduced.

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Spotlight

In the European Union (EU), where strained healthcare systems are facing ever greater demands from an ageing population, generic medicines have played a significant part in controlling costs. Off-patent medicines now account for 92% of the treatment volume in the region. And competition from generic medicines drives the cost of off-patent products down61% from their cost during market exclusivity. This saved payers an estimated €100Bn in 2014 and has contributed to significantly higher access for patients in many countries, across many therapeutic areas. However, over the next several years, the number of small molecule original brands losing their market exclusivity in Europe and the savings opportunities to be had from generic medicines and the competition they create will be dramatically reduced.