Shield Therapeutics plc (STX) , the commercial stage pharmaceutical company, told investors on Wednesday that the Swiss Agency for Therapeutic Products (Swissmedic) has approved a major extension.
The approved indication for Feraccru® will now include treatment of all adults with iron deficiency (ID) with or without anaemia.
Feraccru® was initially approved in both the EU and Switzerland for the treatment of iron deficiency anemia only in adults with inflammatory bowel disease.
The approved label was then also significantly broadened in the EU to all adults with Iron Deficiency with or without anaemia, a market of 40 million patients.
Carl 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.”
Shares in Shield Therapeutics were trading 5.99% higher at 88.5p a share following the news
Carl Sterritt, Chief Executive Officer of Shield Therapeutics, added: "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."
The company is awaiting for its Feraccru® US New Drug Application to be reviewed by the FDA, with a 27 July 2019 target date for review completion.
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