Gateshead firm secures US Food & Drink Administration approval for new drug for adolescents
Shield Therapeutics, which has a base in Gateshead, has secured an extension for its iron deficiency drug, meaning it can now be used by adolescents.
The US Food and Drug Administration (FDA) has approved the extension of the indication for ACCRUFeR (ferric maltol) to include adult and pediatric patients 10 years of age and older.
Shield plans to file for a further extension of the indication to include children one month and above in conjunction with the submission of an NDA for a new pediatric formulation which was used in the successful FORTIS Phase 3 study in this population.
If approved, this formulation may also offer an alternative approach for adults who can't swallow our current capsule formulation.
Anders Lundstrom, chief executive of Shield, said: "We are delighted with the FDA approval of ACCRUFeR, making it available to the adolescent population, who now can benefit from a much needed safe and effective oral iron treatment."