The FDA has stamped an approval on NPS Pharmaceuticals' ($NPSP) Gattex for treating patients with short bowel syndrome. The approval sets the stage for the U.S. launch of the company's lead drug and adds to U.S. regulators' impressive tally of more than 30 new drug nods in 2012.
The sanctioning of Gattex isn't a big surprise. FDA advisers unanimously endorsed the drug, which helps patients with the syndrome reduce their dependence on IV feeding, for approval in October. And most of them backed the REMS plan from the company to monitor cancer and other risks associated with the therapy.
The FDA noted today that patients on Gattex could face "increased risk of developing cancer and abnormal growths (polyps) in the intestine, obstructions in the intestine, gallbladder disease, biliary tract disease and pancreatic disease." The agency previously approved Zorbtive from Merck Serono and NutreStore from Emmaus for patients with short bowel syndrome, which is a relatively rare ailment that affects patients with Crohn's disease after they have a portion of their intestines removed.
"Today's approval expands the available treatment options for patients with this life-threatening condition," said Dr. Victoria Kusiak, of the FDA's Center for Drug Evaluation and Research, in a statement. "Because Gattex may cause other serious health conditions, it is critical that patients and health care professionals understand the drug's potential and known safety risks."
Bedminster, NJ-based NPS has been gearing up for the transition to the commercial realm this year, and CEO Francois Nader told FierceBiotech that 2012 would be transformational for his company back in January. He predicted well. In August, the European Commission green-lighted Gattex, a GLP-2 drug, in the EU where Takeda has marketing rights.
- here's the FDA's release