Regulatory Affairs

Shield receives CHMP positive opinion for Feraccru to treat iron deficiency in adults

Published 26 February 2018

Shield Therapeutics 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.

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).

Shield Therapeutics chief medical officer Dr Mark Sampson 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.

Shield Therapeutics CEO Carl Sterritt 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 deliversignificant value to shareholders.

“Once thisrecommendation isratified by the European Commission in the near term, the market opportunity for Feraccru in Europe significantly expands from the current 300,000 patients with IDA in IBD, to a much broader patient population opportunity, with over 40 million* people in the EU estimated to be iron deficient.”

The AEGIS-H2H Phase 3b study is designed as a non-inferiority trial comparing the efficacy and safety of Feraccru to the market-leading latest generation form of IV iron (Ferinject/Injectafer, ferric carboxymaltose). Primary endpoint data from the AEGIS-H2H study is expected to be available in the second half of 2018.

Source: Company Press Release