Shield Therapeutics said Monday that US Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for its lead product Feraccru.
Under the terms of the Prescription Drug User Fee Act (PDUFA), the FDA will shortly confirm to Shield the expected target date in 2019 for completion of the NDA review and Shield will provide a further update at that time.
Feraccru is already approved in the European Union for the treatment of iron deficiency in adults and in Switzerland for the treatment of iron deficiency anaemia in adults with inflammatory bowel disease. The United States, representing over a third of the global pharmaceutical market, is a highly attractive opportunity for Feraccru and a market which Shield retains full ownership of, as well as complete control of the global intellectual property rights.
In September 2018, Feraccru was licensed to Norgine B.V. in all European territories not already partnered as well as Australia and New Zealand. In return Norgine B.V. paid a licence fee of £11m, with scope for additional milestones totalling EUR54.5m and royalties on sales ranging from 25% up to 40%.
Dr Jackie Mitchell, VP of Regulatory Affairs and Quality at Shield Therapeutics, said: “We are delighted to have achieved this key regulatory milestone in widening Feraccru’s geographical availability for patients suffering from iron deficiency. We look forward to interacting positively with the FDA over the coming months and, if approved, Feraccru will provide a novel and much needed treatment option for patients with iron deficiency.”
Carl Sterritt, Chief Executive Officer of Shield Therapeutics, said that the review by the FDA brings the company a major step closer to Feraccru potentially being approved in the USA in 2019. Sterritt added that the company is well-funded and increasingly excited about Feraccru’s future.