NPS Bowel Drug Gattex’s Risk Plan Gains FDA Staff Support
NPS rose 14 percent in early trading after Food and Drug Administration staff said Gattex, the company’s lead experimental drug candidate, helped wean patients with short- bowel syndrome off a time-consuming intravenous nutrition program. Advisers to the FDA may rely on today’s report when they meet Oct. 16 to vote on whether to recommend the Bedminster, New Jersey-based company’s drug for approval.
The risk-management plan would target Gattex to specialty physicians who understand the dangers associated with the drug, including tumor growth, according to the report. The staff also suggested additional educational materials for prescribers emphasizing the key serious risks. The FDA is scheduled to make a final decision on Gattex by Dec. 30.
“The agency does not believe that access to Gattex for SBS should be restricted or require elements to assure safe use,” FDA staff wrote.
NPS, which reported about $101 million in revenue last year, may see peak annual sales from Gattex reach $350 million if it’s approved, President and Chief Executive Officer Francois Nader said in a telephone interview. The drug is meant to increase the ability of short-bowel syndrome patients to absorb nutrients and replace intravenous nutritional support given 10 to 12 hours each day, which has been the standard treatment for the past 40 years, Nader said.
“Giving them one day of freedom a week is a life-changing event, or two or three,” he said.
The medicine would be used in less than 10,000 patients, Nader estimates.
Short-bowel syndrome is the result of conditions such as Crohn’s disease or trauma that requires much of the small intestine to be removed, causing a reduced ability to absorb water and nutrients.
NPS has proposed prohibiting prescribing Gattex for cancer patients and those who have had the disease in the past five years, Nader said. As many as 20 percent of short-bowel patients had their small intestines removed because of cancer and it’s unclear how many may have had the disease recently, he said.
Three people in a clinical trial of Gattex got cancer and two died, NPS said a year ago. They were among 566 participants who have received the drug in various trials, NPS said in a statement.
An analysis of the trial of 34 patients that took Gattex for one year found eight patients reduced their dependency on intravenous nutrition by three days a week, 13 patients decreased it by two days and 18 were free a day each week from the process, according to the statement.
The advisory committee will discuss whether the results are clinically meaningful. European regulators concluded in May the reduction in intravenous nutrition requirements was meaningful, FDA said.
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