Business
Major extension to approval in Switzerland
Major extension to approval in Switzerland.
About this update from Shield Therapeutics Plc
[{"type":"text","content":"\n \nRNS Number : 8658W Shield Therapeutics PLC 24 April 2019 \n\nShield Therapeutics plc\n(\"Shield\" or the \"Group\")\n \nFeraccru® granted major extension to approval in Switzerland\n \nSwissmedic approves Feraccru® to treat Iron Deficiency with or without anaemia in adults\n \nLondon, UK, 24th April 2019: Shield Therapeutics plc (LSE:STX), a commercial stage, pharmaceutical company with a focus on addressing iron deficiency with or without anaemia via its lead product Feraccru®, announces that the Swiss Agency for Therapeutic Products (Swissmedic) has approved a major extension of the approved indication for Feraccru® to now include treatment of all adults with iron deficiency (ID) with or without anaemia.\n \nThis follows an equivalent broadening of the marketing authorisation approval for Feraccru® in the European Union in 2018 and futher increases the commercial opportunity for Feraccru®, which was initially approved in both the EU and Switzerland just for the treatment of iron deficiency anemia (IDA) in adult patients with inflammatory bowel disease (IBD).\n \nCarl Sterritt, Chief Executive Officer of Shield Therapeutics, said: \"We are delighted with the positive progress we continue to make with regulatory authorities in relation to maximising the commercial opportunity for Feraccru®. Switzerland represents an attractive market opportunity as it is both well reimbursed and has a much higher level of treatment penetration compared to other markets, particularly for IV iron therapies. \n \n\"Together with the new label, we expect the recent positive result from the AEGIS-H2H phase 3b active comparator study of Feraccru® versus intravenously delivered Ferinject® will have added importance and will provide an enhanced commercial opportunity to Ewo, our Swiss commercial partner. We look forward to working with them to deliver commercial success for Feraccru® in Switzerland at the earliest opportunity.\"\n \n- Ends -\n \nFor further information please contact:\n \n\n\n\n\nShield Therapeutics plc\n\n\nwww.shieldtherapeutics.com\n\n\n\n\nCarl Sterritt, Chief Executive Officer\n\n\n+44 (0)20 7186 8500\n\n\n\n\nTim Watts, Chief Financial Officer\n\n\n \n\n\n\n\n \n\n\n \n\n\n\n\nNominated Advisor and Broke...