INDIANAPOLIS—Eli Lilly and Co. has announced that the U.S. Food and Drug Administration (FDA) Gastrointestinal Drugs Advisory Committee voted Jan. 13 to recommend non-approval of liprotamase, a non-porcine pancreatic enzyme replacement therapy (PERT), currently under FDA review for the treatment of exocrine pancreatic insufficiency (EPI).
During the meeting, the committee had questions about the degree of efficacy of liprotamase and recommended that additional studies be conducted prior to considering approval of liprotamase for EPI.
"We appreciate the feedback the committee has provided, and we will continue to work with the FDA to address the questions raised in the meeting as the agency moves toward a final decision on the application," says Dr. Eiry Roberts, vice president of autoimmune, bone-muscle-joint and liprotamase product development at Lilly. "We remain confident in the clinical trial data package submitted to the FDA in support of the liprotamase application."
The FDA is not required to follow the recommendation of its advisory committees.
Patients with EPI cannot properly digest and absorb nutrients including fat, protein and carbohydrates. Causes of EPI include cystic fibrosis (a life-threatening genetic disorder), chronic pancreatitis and pancreatectomy (surgical removal of the pancreas). PERT is a treatment involving the oral administration of pancreatic enzyme replacements, which include protease, amylase and lipase. Lilly notes that cystic fibrosis affects approximately 30,000 children and adults in the United States and nearly 100,000 people worldwide and that approximately 90 percent of cystic fibrosis patients receive PERT.
During the meeting, the committee had questions about the degree of efficacy of liprotamase and recommended that additional studies be conducted prior to considering approval of liprotamase for EPI.
"We appreciate the feedback the committee has provided, and we will continue to work with the FDA to address the questions raised in the meeting as the agency moves toward a final decision on the application," says Dr. Eiry Roberts, vice president of autoimmune, bone-muscle-joint and liprotamase product development at Lilly. "We remain confident in the clinical trial data package submitted to the FDA in support of the liprotamase application."
The FDA is not required to follow the recommendation of its advisory committees.
Patients with EPI cannot properly digest and absorb nutrients including fat, protein and carbohydrates. Causes of EPI include cystic fibrosis (a life-threatening genetic disorder), chronic pancreatitis and pancreatectomy (surgical removal of the pancreas). PERT is a treatment involving the oral administration of pancreatic enzyme replacements, which include protease, amylase and lipase. Lilly notes that cystic fibrosis affects approximately 30,000 children and adults in the United States and nearly 100,000 people worldwide and that approximately 90 percent of cystic fibrosis patients receive PERT.
