Business
Receives CHMP positive opinion on Feraccru®
Receives CHMP positive opinion on Feraccru®.
About this update from Shield Therapeutics Plc
[{"type":"text","content":"\n \nRNS Number : 8217F Shield Therapeutics PLC 23 February 2018 \n\n \nShield Therapeutics plc\n(\"Shield\" or the \"Group\")\nShield receives CHMP positive opinion for Feraccru® (Ferric Maltol) for the treatment of Iron Deficiency in adults\n \nRecommendation for broad label in EU \n \nLondon, UK, 23 February 2018: Shield Therapeutics plc (LSE:STX), a commercial stage, pharmaceutical company delivering innovative specialty pharmaceuticals to address patients' unmet medical needs, with an initial focus on addressing iron deficiency anaemia, today announces that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for the marketing authorisation approval of Feraccru (Ferric Maltol) to be extended to include treatment of all adults with iron deficiency (ID) with or without anaemia, which will provide Feraccru with a much broader commercial opportunity. This recommendation will now go forward to the European Commission for ratification and implementation over the next two to three months. Feraccru, the Company's lead asset, is currently approved and marketed in Europe for the treatment of iron deficiency anemia (IDA), initially in patients with inflammatory bowel disease (IBD).\n \nDr Mark Sampson, Chief Medical Officer of Shield Therapeutics, said: \"We are pleased to receive this positive opinion from the CHMP for Feraccru and it is an important step for Shield and for patients suffering with iron deficiency be that with or without anaemia. Iron deficiency causes significant morbidity and failure to be able to treat it adequately with current therapies can cause the disease to progress to iron deficiency anaemia. The WHO has identified that iron deficiency is a globally important health issue significantly impacting the lives up to 2 billion people.\"\n \nCarl Sterritt, Chief Executive Officer of Shield Therapeutics, said: \"As we announced yesterday, the Board has initiated a complete review of the various strategic options available to the Company, particularly the options for Feraccru to deliver significant value to shareholders. Once this recommendation is ratified by the European Commission in the near term, the market opportunity for Feraccru in Europe significantly expands from ...