Shield Therapeutics (STX) has seen shares soar over 70% today following the news that the US FDA has approved its lead product Feraccru with a broad label of treating iron deficiency in adults.
The long awaited result is a significant step forward in the company’s pursuit of commercialising in the US, a massive iron replacement therapy market said to be worth over $1 billion annually.
Importantly, the designation of a broad label by the FDA means Feraccru, or as it will be marketed in the US, Accrufer, would be able to treat not only the 8 to 9 million patients who suffer from iron deficiency anaemia but also the population that is iron deficient, “potentially two to three times” the size of iron anaemia.
The drug’s edge on alternatives in the marketplace is that it can provide an oral therapy option for patients who have traditionally had to opt for intravenous solutions.
CEO of Shield Therapeutics Carl Sterritt expressed his “delight” at the news, “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."
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