SAN FRANCISCO, May 1 — The FDA has approved the Creon brand of delayed-release pancrelipase for treatment of exocrine pancreatic insufficiency.

Creon pancrelipase is the first drug in the pancreatic enzyme class to meet the FDA’s 2004 requirement that these agents go through the New Drug Application process in order to remain on the market.

The drugs had never gone through the formal approval process because the original products predated modern FDA regulations, so each manufacturer now must seek approval.

At least five companies market pancrelipase under different names, and Creon was the first to complete the FDA process.

Creon’s manufacturer, Solvay Pharmaceuticals of Marietta, Ga., said it expects to make the currently-marketed formulation available until the FDA-approved formulation is launched later this year.

The updated formulation no longer contains dibutyl phthalate in the enteric coating, or mineral oil, which the company said should not affect efficacy.

Although the label dose will remain the same, the newly approved capsules will no longer be overfilled and will contain the exact amount of lipase indicated on the label, the company said.

Pancreatic enzyme product capsules were typically overfilled based on manufacturing standards that allowed a range of lipase content from 90% to 165% of label claims. But the FDA called for a “zero overfill” target.

Exocrine pancreatic insufficiency affects more than 80% of patients with cystic fibrosis, starting as early as the first year of life, and occurs with other conditions such as pancreatic cancer, gastrointestinal surgery, and chronic pancreatitis.

Pancreatic enzyme products replace these digestive enzymes in the small intestine to help break down fats, proteins, and carbohydrates in food. Without them, maldigestion, malabsorption, and malnutrition can be life threatening.

Approval for Creon was based on demonstration of efficacy in a randomized, double-blind, placebo-controlled cross-over study.

In the 32 participants with cystic fibrosis, pancrelipase improved the coefficient of fat absorption — the percentage of fat absorption relative to dietary fat intake — by an absolute 41% compared with placebo (mean 89% versus 49%).

The study also showed significantly better fat absorption across age groups, with similar benefits for adults and adolescents age 12 to 18.

Overall, the drug appeared well tolerated compared with placebo. Treatment-emergent adverse events occurring in at least 6% of patients, including abdominal pain, abdominal pain upper, abnormal feces, cough, dizziness, flatulence, headache, and weight loss.

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