AstraZenecaannounced promising results from the pooled cardiovascular safety analyses of the global Phase III program for a drug for the treatment of a condition related to kidney disease
The global Phase III trials evaluated roxadustat for treatment of anemia in patients with chronic kidney disease in various groups.
Mene Pangalos, executive vice president, R&D BioPharmaceuticals, said: “We are pleased to report these data from the largest clinical program 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 anemia 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.”
AstraZeneca and San Francisco-based FibroGen Inc.) 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. Roxadustat is currently approved in China for the treatment of patients with a type of anemia.
FibroGen, the originator, and AstraZeneca are collaborating on the development and commercialization of roxadustat for the treatment of anemia in patients with CKD in the US, China, and other global markets.
FibroGen and Tokyo-based Astellas Pharma Inc. are collaborating on the development and commercialization of roxadustat for the treatment of anemia in patients with other nations.
AstraZeneca is based in the United Kingdom and employs 1,500 in northern Delaware.
The global Phase III program consists of more than 9,000 patients and was conducted by AstraZeneca, FibroGen and Astellas.