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Shield Therapeutics buoyed by recommendation from medicinal committee
Shield Therapeutics' Feraccru product received a positive opinion from the Committee for Medicinal Products for Human use (CMPH) on Friday.
The CMPH, a part of the European Medicines Agency (EMA), adopted a positive opinion for the marketing authorisation approval of the product to be extended to include the treatment of patients with iron deficiency, with or without anaemia.
The company said this will provide Feraccru with a much broader commercial opportunity.
Mark Sampson, chief medical officer of Shield, said: "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."
Feraccru is an oral ferric iron therapy, initially for use in patients with inflammatory bowel disease as a result of iron deficiency anaemia.
Following the recommendation from the CMPH the product will go forward to the European commission for ratification and implementation in the next two to three months.
Carl Sterritt, chief executive of Shield said: "Once this recommendation is ratified 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. With Feraccru being protected by a composition of matter patent through to 2035, this a valuable step forward for the Company."
Friday's news comes after the product received less than satisfactory results from an AEGIS-CKD study in the United States, crushing the company's hopes of expanding into the US market and sending its shares into freefall.
This led to a warning from the company on Thursday that it would have to "significantly" reduce its headcount.
As of 1426 GMT, Shield Therapeutics' shares were down 2.13% at 23.00p.