Despite a positive opinion from local drug reviewers, GSK has decided not to bring its FDA-approved oral anemia drug daprodustat to Europe—or any additional countries for that matter.
GSK plc (LSE/NYSE: GSK) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has issued a positive opinion recommending authorisation of daprodustat, an oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), for the treatment of symptomatic anaemia associated with chronic kidney disease (CKD) in adults on chronic maintenance dialysis.
Feb 1 (Reuters) - The U.S. Food and Drug Administration (FDA) on Wednesday approved GSK Plc's (GSK.L) drug as the first oral treatment for anemia caused by chronic kidney disease in adults who have been on dialysis for at least four months.
GSK reports outcome from US FDA Advisory Committee meeting on daprodustat for anaemia of CKD
The FDA’s Cardiovascular and Renal Drugs Advisory Committee tomorrow will vote on whether the benefits of GSK’s daprodustat, an oral hypoxia-inducible factor-prolyl hydroxylase inhibitor, outweighs its risks for the treatment of anemia due to chronic kidney disease (CKD) in adult patients not on dialysis and on dialysis.
GSK has said that its daprodustat for anaemia associated with chronic kidney disease (CKD) will have to face an FDA advisory committee before the US regulator delivers a verdict on the drug early next year.
The FDA has accepted GSK’s application for daprodustat as an oral therapy for patients with anemia of chronic kidney disease (CKD), the company said Tuesday. The FDA plans to deliver its daprodustat verdict by Feb. 1, 2023, GSK said.
GlaxoSmithKline plc (GSK) announced that the European Medicines Agency (EMA) validated the marketing authorisation application (MAA) for daprodustat, an investigational oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), for the treatment of patients with anaemia of chronic kidney disease (CKD). Daprodustat was developed based upon the unique Nobel Prize-winning science that demonstrated how cells sense and adapt to oxygen availability.
GlaxoSmithKline has boosted its challenge for the anemia due to chronic kidney disease market, revealing a clean sweep of hits on key endpoints across two phase 3 clinical trials. But with the FDA rejecting AstraZeneca’s rival drug, doubts remain about GSK’s chances of getting to market.
GlaxoSmithKline (GSK) has revealed positive data for its investigational oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI) daprodustat in patients with anaemia due to chronic kidney disease (CKD).