NPS says FDA committee will review Gattex in Oct.The Associated Press
BEDMINSTER, N.J. -- NPS Pharmaceuticals Inc. said Tuesday that a Food and Drug Administration advisory committee will begin a review of its bowel drug Gattex on Oct. 16.
The committee will review NPS' application to market the drug as a treatment for short bowel syndrome and will look at the safety and effectiveness data NPS has gathered from clinical trials. A positive recommendation would make it more likely the FDA will approve Gattex.
Short bowel syndrome is a potentially life-threatening chronic condition that prevents patients from absorbing nutrients from food. People with short bowel syndrome are prone to malnutrition, diarrhea and dehydration.
The FDA is scheduled to complete its review of Gattex by Dec. 30. The agency was originally expected to make a decision by Sept. 30, but NPS said earlier this month that the FDA will take three more months to review new data.
Shares of NPS Pharmaceuticals rose 26 cents, or 3.3 percent, to $8 in midday trading.