Abbott Receives FDA Approval For Creon Capsules
Prior to this FDA approval, dosing guidance for medications such as CREON was based on patients with cystic fibrosis.
The supplemental new drug application (sNDA) approval was based on results of a double-blind, randomized, placebo-controlled, two-arm, parallel-group study which enrolled 54 adults with EPI due to chronic pancreatitis (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 claims 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 the 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."
Will the approval benefit prescribers by providing appropriate dosing information?
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