GlaxoSmithKline shares decreased 0.6% to 1,761.8p in early morning trading on Tuesday, after the company announced its accepted Food and Drug Administration (FDA) application for its chronic kidney disease anaemia treatment daprodustat.
The application was reportedly accepted following GlaxoSmithKline’s ASCEND phase three programme, which consisted of five trials which successfully met their primary efficacy and safety endpoints in both non-dialysis and dialysis patients.
The trials covered 8,000 patients over 4.2 years, with the results presented at the American Society of Nephrology’s Kidney Week last year.
The pharmaceutical giant commented that the drug was developed to provide patients with a convenient oral treatment for chronic kidney disease-linked anaemia complications.
The treatment was based on Nobel Prize-winning scientific breakthroughs, which demonstrated how cells sense and adapt to the availability of oxygen in the human body.
The move marks the third regulatory step in the treatment’s advancement after it achieved marketing authorisation approval from the European Medicines Agency (EMA) and secured regulatory submission acceptance and approval in Japan under the label Duvroq for renal anaemia.