Shield Therapeutics' MAA for Ferracru accepted for review by EMA

Independent UK pharma company Shield Therapeutics has received acceptance for review of the Marketing Authorization Application for Ferracru (ST10, ferric maltol) by the European Medicines Agency.

The company is seeking marketing authorization for Ferracru in the treatment of iron deficiency anemia, initially in inflammatory bowel disease and those intolerant of oral ferrous therapies. It would then provide an effective alternative to those patients whose only current option is intravenous iron therapy. Intravenously-administered iron comes with the risk of serious and life-threatening hypersensitivity reactions.

The application is based on the positive results of the AEGIS Phase III trial, which showed that Ferracru delivered a mean increase in hemoglobin levels of 2.3g/dL in 12 weeks, meeting the primary endpoint of hemoglobin change compared to placebo (p<0.0001).