The UK’s Shield Therapeutics has successfully submitted an application to market iron deficiency therapy Feraccru in the US.
Feraccru, Shield’s lead product, 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 US, which represents over a third of the global pharmaceutical market, “is a very attractive opportunity for Feraccru,” the firm said, also noting that it retains full ownership of the product in the territory.
Last month the company signed deal with Norgine giving the latter right to sell Feraccru in the Europe, Australia and New Zealand.
This drug’s submission in the US “is a key regulatory milestone in widening Feraccru’s geographical availability for patients suffering from iron deficiency and it builds on the significant broadening of the product’s indication from patients with anaemia and inflammatory bowel disease to the treatment of all adults with iron deficiency with or without anaemia approved in the European Union earlier this year,” said Dr Jackie Mitchell, VP of regulatory affairs and quality at Shield.