Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Abbott has received FDA approval for the supplemental new drug application (sNDA) of Creon (pancrelipase) delayed-release capsules that now includes dosing guidance in the prescribing information specific to patients with limited production of enzymes in the pancreas due to chronic pancreatitis (CP) or removal of the pancreas (pancreatectomy).
Subscribe to our email newsletter
The sNDA approval was based on results of a double-blind, randomised, placebo-controlled, two-arm, parallel-group study which enrolled 54 adults with EPI due to CP or pancreatectomy. The primary efficacy endpoint was a clinical measurement of how much fat consumed by a patient is absorbed by the body rather than excreted.
Abbott said that prior to this FDA approval, dosing guidance for medications such as Creon was based on patients with cystic fibrosis.
Abbott claimed that with this FDA approval, Creon is the first medication in its class to have this guidance and information in its prescribing information for use in treating EPI due to CP and pancreatectomy.
Orelle Jackson, executive director of National Pancreas Foundation, said: “Without proper dosing guidance, some patients have previously attempted to control EPI symptoms by modifying their diets and limiting fat intake. However, this approach has yielded limited treatment success.”
David Whitcomb of University of Pittsburgh Medical Center, said: “Until now, patients who have had their pancreas removed or those with chronic pancreatitis have too often received inadequate doses of pancreatic enzymes to address their symptoms.
“The availability of new data for Creon is a benefit to prescribers by providing appropriate dosing information that can impact the treatment of these patients.”