The US Food and Drug Administration (FDA) has accepted for review US-based biopharmaceutical firm NPS Pharmaceuticals' supplemental new drug application (sNDA) for Gattex (teduglutide [rDNA origin]) for injection.
In the US, Gattex is used for the treatment of adult patients with Short Bowel Syndrome (SBS) who are dependent on parenteral support.
NPS is looking for additions to the product label for long-term data from STEPS 2, a two-year open-label extension trial, under which 88 adult patients with SBS dependent on parenteral support were given Gattex 0.05 mg/kg/day.
According to the company, acceptance of the sNDA indicates that the application is sufficiently complete to permit a substantive review, while the application has been assigned a Prescription Drug User Fee Act (PDUFA) date of 28 June 2014.
NPS Pharmaceuticals executive vice president and chief medical officer Roger Garceau said, "The data from STEPS 2 we're proposing to include in the label show that patients on Gattex treatment beyond one year continue to achieve clinically meaningful reductions in parenteral support requirements, with some achieving complete independence."
Gattex for injection for subcutaneous use is a new, recombinant analog of human glucagon-like peptide 2, a protein involved in the rehabilitation of the intestinal lining.
The company said that teduglutide has orphan drug status for the treatment of SBS from the European Medicines Agency (EMA) and the FDA.