Shield Therapeutics, a commercial-stage, a pharmaceutical company with a
focus on addressing iron deficiency, announces that the U.S. Food and Drug Administration (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 $1.0bn 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 requires 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 noninferiority 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.
Together with its advisors, Shield is in discussions with a number of potential commercial partners for the US opportunity for Accrufer® and looks forward to providing updates on these discussions in due course. Feraccru® is already approved in both the European Union and Switzerland for the treatment of iron deficiency in adults and commercialisation activities in these territories are progressing well via Shield’s licensing partners.
Carl Sterritt, CEO of Shield Therapeutics:
“We are delighted that the FDA has approved the new drug application for our lead asset. This is a further major milestone for the Company which we have worked tirelessly to achieve, and I am very proud to lead the team within Shield that has made this happen. With this broad approval and IP protection out to 2035, Feraccru®/ Accrufer® has a real and very attractive long-term market opportunity to exploit in the USA. We have been pleased with the levels of interest and engagement shown by 3rd parties in commercialising Accrufer® in the USA and we look forward to finalising these discussions and appointing a commercial partner in the world’s most attractive pharmaceutical market, so that more patients with iron deficiency can benefit from treatment with Accrufer® at the earliest opportunity.”
Jackie Mitchell, VP Regulatory Affairs of Shield Therapeutics:
“The broad label that the FDA has granted provides a very strong signal as to the tolerability and efficacy profile of Feraccru®/ Accrufer® and provides a novel and convenient treatment alternative to the millions of US patients who routinely suffer from iron deficiency. We believe that this broad approval, together with the recent clinical trial data on Feraccru® that showed it to be non-inferior in treatment effect to Ferinject®/ Injectafer®, the leading IV iron therapy, can lead to a change in the current paradigm for the treatment iron deficiency anaemia.”