Abbott Receives FDA Approval For CREON® (Pancrelipase) Infant-Specific Dosage For Patients With Exocrine Pancreatic Insufficiency Due To Cystic Fibrosis

First infant-specific dosage strength now approved by the FDA



Abbott Park, Illinois (NYSE: ABT) — Abbott announced today that the U.S. Food and Drug Administration (FDA) has approved an infant-specific dose of CREON® (pancrelipase) Delayed-Release Capsules to treat exocrine pancreatic insufficiency (EPI) due to cystic fibrosis (CF). The CREON 3,000 units of lipase capsule provides the lowest dosage strength in the class approved by the FDA. This new option will enable more precise dosing titration in accordance with the Cystic Fibrosis Foundation guidelines for infant dosing.

Most infants with CF require small doses of pancreatic enzyme replacement therapy (PERT) with every feeding. 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 new 3,000 units of lipase capsule will allow parents and caregivers to provide a more precise dose of lipase at every feeding.

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.

"We know that the need for consistent, precise dosing of pancreatic enzyme replacement therapy is critical for infants and children living with cystic fibrosis" said Eugene Sun, M.D., vice president, Global Pharmaceutical Development, Abbott.

"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"

In addition, Abbott serves CF patients’ unique health needs with the CFCareForward program, which provides nutritional support for eligible patients in the form of multivitamins at no charge and other resources that support the needs of patients with CF. CREON is the pancreatic enzyme chosen to treat three out of four CF patients in the United States, and as patients age and their needs evolve, CFCareForward evolves with them, providing a range of support options for every stage of life.

About CREON

CREON (pancrelipase) Delayed-Release Capsules is a prescription pancreatic enzyme medicine used to improve food digestion in people who cannot digest food properly because they have exocrine pancreatic insufficiency.

CREON is available by prescription, to be taken with each meal and snack. CREON is dosed by lipase units and is available in four lipase unit strengths (3,000 / 6,000 / 12,000 / 24,000 units of lipase).
Important Information about CREON®

CREON may increase the chance of having a serious bowel disorder called fibrosing colonopathy. ;The risk of having this condition may be reduced by following the dosing instructions.

CREON capsules or the contents of the capsules should not be crushed or chewed because this may cause mouth irritation. CREON should be taken during a meal or a snack and followed with sufficient fluid.

CREON can cause allergic reactions such as unusual or severe stomach pain, worsening of gout, or painful, swollen joints, trouble with breathing, skin rashes, or swollen lips.

The most common side effects include: gassiness (flatulence), headaches, stomach area (abdominal) pain, dizziness, hyperglycemia and hypoglycemia.

CREON and other pancreatic enzyme products are made from the pancreas of pigs, the same pigs people eat as pork These pigs may carry viruses. Although it has never been reported, it may be possible for a person to get a viral infection from taking pancreatic enzyme products that come from pigs.

About Cystic Fibrosis

CF is a genetic disease that affects 30,000 children and adults in the United States. The disease causes production of thick mucus most commonly in the lungs and pancreas. As mucus build-up increases in the lungs, breathing can become difficult; the mucus can also obstruct the pancreas and stop natural enzymes from helping the body break down and absorb food. Today, more than 45 percent of people living with CF are aged 18 or older.

About CFCareForward

The CFCareForward program provides comprehensive nutritional, educational and financial support for patients living with CF and their families.

About Abbott

Abbott (NYSE: ABT) is a global, broad-based health care company devoted to the discovery, development, manufacture and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs nearly 90,000 people and markets its products in more than 130 countries.