FDA approves Accrufer to treat iron deficiency

Shield Therapeutics plc announces that the FDA has approved its lead product Feraccru / Accrufer 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.

Accrufer ’s confirmed efficacy, together with its good tolerability and mode of absorption - by which the body absorbs only as much iron from Accrufer as it needs - means that the product could be the ideal choice for iron deficient patients who cannot tolerate salt-based oral iron alternatives. These features, combined with the non-inferiority results from the AEGIS-H2H study announced in March 2019, mean that treatment with Accrufer might remove the need for patients to progress to intravenous iron therapy, leading to a change in the current paradigm for the treatment of iron deficiency anaemia.