US regulators have accepted Sheild Therapeutics New Drug Application (NDA) for its lead product Feraccru.
Feraccru is already approved in the EU for the treatment of iron deficiency in adults and in Switzerland for the treatment of iron deficiency anaemia in adults with inflammatory bowel disease.
In September 2018, Feraccru was licensed to Norgine for £11 million in all European territories not already partnered as well as Australia and New Zealand.
Shield said that the US is a “highly attractive opportunity” for Feraccru.
Carl Sterritt, Shield CEO, said: “News that the NDA has been validated and accepted for review by the FDA brings us a major step closer to Feraccru potentially being approved in the USA in 2019.
“Following the licensing agreement we signed with Norgine in September for the commercialisation of Feraccru in Europe, Australia and New Zealand, we are well-funded and are increasingly excited about Feraccru’s future as we continue to enact our plans to realise the value creation opportunities that lie ahead for Shield and its shareholders.”