Fierce Pharma recently reported that GSK’s oral anemia drug, Jesduvroq, has scored partial FDA approval after two rivals previously suffered rejections. George Clinical’s global and national scientific leadership helped move the breakthrough CKD anemia treatment forward via the collaboration between the organization’s exceptional kidney and metabolic scientific leadership network and GSK. The network provided continuity, communication and cultural expertise in the long-term global trial.
“After two prior FDA rejections for oral anemia drugs in the hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) drug class, GSK’s daprodustat, branded as Jesduvroq, has won a class-first approval. Specifically, the drug is approved to treat patients with anemia caused by chronic kidney disease who have been on dialysis for at least four months,” Zoey Becker reported.
Long-term global trials face challenges including recruitment and retention and in the case where a long-running trial involves patients with poor health conditions, such as CKD anemia, these issues become even more critical. The effort, named ASCEND, was a multi-trial, multi-year program spanning more than 40 countries creating many logistical challenges and a high risk of dropouts. In addition, there were language and cultural issues as well as nuances in treatments and clinical practices from country to country and even site to site. It should also be noted that much of the program was conducted during the COVID-19 pandemic, adding further challenges and stresses to all involved.
The National Institute of Diabetes and Digestive and Kidney Diseases (NIH) estimates that more than one in seven people with kidney disease have anemia, increasing their chance of developing heart problems and strokes. The prevalence of anemia increases as chronic kidney disease (CKD) progresses and is associated with an increased risk of hospitalization, cardiovascular complications and death. CKD is a significant global burden with more than 700 million people worldwide living with CKD.