Abbott wins FDA approval for infant CF dose

Abbott has secured Food and Drug Administration (FDA) approval for an infant-specific dose of CREON (pancrelipase) delayed-release capsules to treat exocrine pancreatic insufficiency (EPI) caused by cystic fibrosis (CF).

The CREON 3,000 units of lipase capsule provides the lowest dosage strength in the class approved by the FDA, which enable more precise dosing titration in accordance with the Cystic Fibrosis Foundation guidelines.

Most infants with CF require small doses of pancreatic enzyme replacement therapy (PERT) with every feed. Until now, parents or caregivers administering an infant dose of PERT have had to open a capsule of a larger dose and measure out a portion of the contents.

The majority of people living with CF suffer from EPI. They are unable to properly digest food because their bodies do not produce enough pancreatic enzymes, which may lead to malnutrition. The pancreatic enzymes in CREON capsules work directly in the intestines to help break down fats, proteins and carbohydrates, allowing the body to better digest nutrients from food.

Dr Eugene Sun, vice president of global pharmaceutical development at Abbott, said: "We know that the need for consistent, precise dosing of pancreatic enzyme replacement therapy is critical for infants and children living with cystic fibrosis.

"This approval means that CREON will now be available in four dosing options, including both the lowest and highest dosage strengths available to patients in the United States, providing improved dosing titration options and flexibility into adulthood," he added.