North East pharmaceuticals firm Shield Therapeutics says a decision which doubles its lead drug’s shelf life will support its US expansion.
The Gateshead company’s main drug, which treats iron deficiency anaemia, was first launched in Europe under the Ferracru brand in 2019 but is now available in the US and other countries outside Europe as Accrufer. Now the firm has announced that US Food and Drug Administration (FDA) has approved the extension of the expiration for Accrufer from 36 months to 48 months.
The move will, it says, aid its growth in the US, where the product was launched last year, having taken four years to get through the approval process.