The US Food and Drug Administration (FDA) has accepted for review NPS Pharmaceuticals, Inc.'s Supplemental New Drug Application (sNDA) for Gattex (teduglutide [rDNA origin]) for injection.
In the US, Gattex is indicated for the treatment of adult patients with Short Bowel Syndrome (SBS) who are dependent on parenteral support. The company is seeking additions to the product label for long-term data from STEPS 2, a two-year open-label extension study in which 88 adult patients with SBS dependent on parenteral support received Gattex 0.05 mg/kg/day.
Acceptance of the sNDA indicates that the application is sufficiently complete to permit a substantive review. The application has been assigned a Prescription Drug User Fee Act (PDUFA) date of June 28, 2014.
“We are pleased that the FDA has accepted our sNDA for review,” said Roger Garceau, MD, FAAP, executive vice president and chief medical officer of NPS Pharmaceuticals. “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. This is encouraging for patients with Short Bowel Syndrome, as the ability to reduce or even completely eliminate the need for parenteral support could meaningfully impact their lives.”
Gattex (teduglutide [rDNA origin]) for injection for subcutaneous use is a novel, recombinant analog of human glucagon-like peptide 2, a protein involved in the rehabilitation of the intestinal lining. Gattex is indicated for the treatment of adult patients with Short Bowel Syndrome (SBS) who are dependent on parenteral support. Significant reductions in mean PN/IV infusion volume from baseline to end of treatment were seen in the phase III studies of Gattex. In addition, some patients were able to achieve independence from PN/IV support during these trials. The most common side effects of Gattex include stomach area (abdomen) pain or swelling, skin reaction where the injection was given, nausea, headache, cold or flu like symptoms, vomiting, and holding too much fluid in the body (swelling of face, ankles, hands or feet).
The European Commission granted European market authorization on August 30, 2012 for the medicinal product teduglutide (trade name in Europe: Revestive) as a once-daily treatment for adult patients with SBS. NPS is preparing to engage in the pricing and reimbursement processes in key European countries with the goal of commercially launching Revestive in Europe in the first half of 2014.
Teduglutide has orphan drug designation for the treatment of SBS from the European Medicines Agency (EMA) and the FDA.