Shield expects the U.S. to make a decision on Ferracru in July
Last Update: 2021-02-27
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the U.S. Food and Drug Administration will decide by July 27 next year to apply it to Feraccru in the U.S. market, according to Shield Therapeutics, a U.S. food and drug administration official.
Feraccru is the company's main product for low iron storage in the body, is a new, stable, salt-free, oral tricolor iron preparation, compared with salt-based oral iron agent has a different mechanism of effect.
in clinical trials, patients showed good tolerance, even if they had not previously been treated with salt-based oral iron therapy, which would lead to increased patient compliance and better prognostication.
Feraccru has been approved by the European Union for the treatment of iron deficiency in adults, and the Swiss treatment of iron deficiency anemia in adult inflammatory bowel disease was launched in the UK earlier this month.
Currently in the United States, the only treatment option for IDA patients who are not resistant to salt-based oral iron therapy is intravenous iron therapy, which is invasive, expensive, inconvenient and complex to administer, and can also cause life-threatening reactions.
"We are pleased to be able to confirm the PDUFA Target Review Action Date, which is a key regulatory milestone in expanding Feraccru's geographic availability for iron-deficupulated patients," said Dr. Jackie Mitchell, Shield's vice president of quality and regulatory affairs, referring to this development. If approved, Feraccru will provide a novel and much-needed treatment for people with iron deficiency. " (Compiled by this web)
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