Advisors to the US Food and Drug Administration have given their backing to NPS Pharmaceuticals' Gattex for the treatment of short bowel syndrome.
The agency's Gastrointestinal Drugs Advisory Committee voted unanimously to recommend approval of Gattex (teduglutide). It voted 12-0 that the drug delivered meaningful benefits as a treatment for SBS and that the benefits of the drug outweigh its potential risks.
SBS is a disorder in which the body is unable to absorb enough nutrients and fluids through the gastrointestinal track to sustain life. Gattex, a recombinant analogue of human glucagon-like peptide 2 (GLP-2), is now likely to be the first FDA-approved therapy indicated for the long-term treatment of the problem.
The New Drug Application for Gattex was based on data from 14 completed and one ongoing clinical study involving 566 subjects treated with the drug. Across the company’s Phase III studies, a total of 15 patients were able to achieve independence from parenteral nutrition and intravenous fluids, which do not treat the underlying disorder, while on Gattex.
NPS also unveiled fresh data showing that five additional patients have successfully achieved independence from PN/IV while on long-term Gattex therapy in a 24-month open-label study. Chief executive Francois Nader said the unique mechanism of Gattex "could make it the first and only long-term therapy that treats the underlying cause of this rare disorder", adding that with 14% of patients "completely eliminating the need for parenteral support…we believe Gattex could be a life-changing therapy for patients with SBS".
The FDA panel's recommendation comes just over a month after regulators in Europe approved the drug, where it is known as Revestive. The therapy is to be marketed by Takeda.