GSK’s Daprodustat Effective in Chronic Kidney Disease Patients
Two pivotal Phase 3 trials found that GSK’s drug improved or maintained chronic kidney disease patients within their target hemoglobin range.
Source: Getty Images
By - GSK recently announced that its drug, daprodustat, was safe and effective in patients with anemia due to chronic kidney disease (CKD).
The Phase 3 ASCENT trial studied the hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) in 8,000 patients over 4.26 years. Daprodustat was well tolerated in both non-dialysis and dialysis populations.
Specifically, two pivotal Phase 3 studies, published in the New England Journal of Medicine, focused on non-dialysis (ASCEND-ND) and dialysis (ASCEND-D) patients.
The ASCEND-ND and ASCEND-D studies met their primary efficacy and safety endpoints. In both trials, daprodustat improved or maintained patients within their target hemoglobin range.
The ASCEND-ND trial found a hazard ratio reflecting the time to first occurrence of major adverse cardiovascular events (MACE) of 1.03. And the ASCEND-D trial found a hazard ratio reflecting the time to first occurrence of MACE of 0.3.
Therefore, both trials achieved non-inferiority.
The most common adverse events in the trials were minimal. Daprodustat is the first oral HIF-PHI to show positive efficacy and no increased cardiovascular risk across both populations.
Over 700 million people suffer from CKD globally. And about one in seven of these patients suffer from anemia, explained Hal Barron, MD, chief scientific officer and president of research and development at GSK.
“Grounded in research based on Nobel Prize-winning science, we believe these data show daprodustat has the potential to transform the treatment landscape for these patients, many of whom have limited treatment options today,” Barron continued.
In addition to the primary analysis, the ASCEND-TD trial showed positive efficacy results for three-times-weekly dosing, in addition to the once-daily dosing regimen evaluated in the ASCEND-ND and ASCEND D trials.
And the ASCEND-NHQ and ASCEND-ID trials found that daprodustat led to significant improvement in non-dialysis dependent patients’ hemoglobin levels and maintained hemoglobin levels in the high-risk incident dialysis population, compared to placebo.
Currently, daprodustat is approved in Japan for patients with renal anemia. But the drug is not approved anywhere else in the world.
“It’s extraordinary to see how this work has been translated into positive clinical evidence within the ASCEND program. The data shared today demonstrate the importance of following the science and how better understanding the body’s natural responses enables us to create medicines that can have a meaningful impact on patients’ lives,” said Sir Peter J. Ratcliffe, professor of medicine at the University of Oxford, Francis Crick Institute and Novel laureate.
