FDA approves Feraccru with broader than expected label of treating iron deficiency in adults
UK drugmaker Shield Therapeutics (LSE:STX) saw its shares soar more than 64% to 169.90 pence in early trading this morning, on the news that the US Food and Drug Administration has approved its lead product Feraccru/Accrufer (ferric maltol) for the treatment of iron deficiency in adults.
With this broad label approval Accrufer (as the product will be marketed in the USA) has taken a big step towards exploiting the very large commercial opportunity in the USA, the world’s largest and most attractively reimbursed pharmaceutical market. Market research suggests that the prescription market for iron replacement therapy in the USA is worth over $1.0 billion annually. There are between 8 million and 9 million patients in the USA who suffer from iron deficiency anaemia and management estimate potentially two to three times this number require treatment for iron deficiency, according to the company.
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