The company, which is focussed on addressing iron deficiency, in a statement explained that the study was intended to provide data comparing oral Feraccru /Accrufer against intravenous iron therapy, to allow economic data capture and analysis.
It was not intended as registration study and its regulatory status are unaffected by the study, Shield added.
Back in March, the company launched a thorough and complete review of that analysis as it announced that the primary endpoint had not been reached. The review work is now complete.
The reanalysis confirms that Feraccru/Accrufer is a credible alternative to IV therapy for iron deficiency anaemia, and, corrects anaemia and maintains iron levels over the long term.
"We are very pleased that the reanalysis of the AEGIS-H2H study data demonstrates that Feraccru/Accrufer is a credible alternative to IV therapy and offers economic advantages,” said Tim Watts, Shield chief executive.
“Having resolved the anomalies seen in the original analysis the study results can now be used with confidence for further health economics analysis and to support pricing and reimbursement applications in Europe."
Dr Stephanie Howaldt, one of the study investigators, meanwhile, added: “In my daily clinical practice, I am looking for an effective, easy to use, well-tolerated and cost-efficient long-term therapeutic approach treating patients with IDA.
“This analysis showed clinical meaningRead More – Source