Please login to the form below

Not currently logged in
Email:
Password:

Abbott wins FDA approval for infant CF dose

Abbott has secured approval for an infant-specific dose of CREON (pancrelipase) to treat exocrine pancreatic insufficiency caused by cystic fibrosis (CF)

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.

15th June 2011

Share

Featured jobs

Subscribe to our email news alerts

PMHub

Add my company
Frontera Group

Welcome to Frontera Group where our agencies immerse you into the world of the patient....

Latest intelligence

Combined immunotherapies – potential and pitfalls
‘Combining therapeutic compounds is the first logical step towards better results, namely higher rates of patients responding to treatment, with deeper and more sustained responses’...
Report: Achieving launch excellence in the challenging healthcare markets of today
Our in-depth report is based on original data and expert interviews, which coupled with our own experience, ensures we give you the best recommendations for achieving launch success in challenging...
What is blockchain and why should i care - Richard Springham
Four Health - Emerging Technologies The power of blockchain lies in the fact it can prove that a unique event occurred at a certain time with out the need to...

Infographics