After an initial rejection due to safety issues, followed by a dispute and deferred actions, Akebia Therapeutics on Wednesday finally won the FDA’s nod for vadadustat as a treatment for anemia caused by chronic kidney disease.
Tag Archive for: chronic kidney disease
The regulator concluded that Prolia (denosumab) increases the risk of severe hypocalcemia, which may result in hospitalization and could trigger life-threatening events or even lead to death.
The company’s resubmission succeeded in getting the greenlight for tenapanor, now to be marketed as Xphozah, to lower serum phosphorus levels in chronic kidney disease patients.
Dialysis giant DaVita raised concerns over Novo Nordisk’s interim analysis of a kidney outcomes study of semaglutide, pointing to the potentially limited applicability of the findings.
Following the recommendations of an independent Data Monitoring Committee, Novo Nordisk has halted a Phase III kidney outcomes study of semaglutide ahead of schedule due to strong efficacy signals.
Britain’s AstraZeneca said it will pay $425 million to settle lawsuits in the United States that claimed its heartburn drugs Nexium and Prilosec caused chronic kidney disease.
The FDA has approved Lexicon Pharmaceuticals’ sotagliflozin, now to be marketed as Inpefa, as a once-daily oral medication to cut the risk of cardiovascular death and heart failure admissions and visits in adult patients with underlying heart failure, the company announced Friday.
The U.S. Food and Drug Administration (FDA) on Wednesday approved GSK Plc’s 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.
The pharma titan adds an intriguing blood pressure medication to its line up with a buyout of CinCor.
After examining the available information and hearing the testimony of CKD patients who participated in the clinical studies, the majority of the committee agreed the benefits of the medication outweighed its risks as a monotherapy.
