Digestive Care, Inc. (DCI) and its marketing partner in the U.S. cystic fibrosis community, Chiesi USA, Inc., announced U.S. Food and DrugAdministration (FDA) approval for an infant-specific dose of PERTZYE® (pancrelipase) in a 4,000 USP lipase units capsule. The new capsule strength will enable guideline-recommended dosing and administration of PERTZYE for infants (up to 12 months) with exocrine pancreatic insufficiency (EPI) due to cystic fibrosis or other conditions.
The recommended dose of PERTZYE in infants is 4,000 USP lipase units, one capsule, per 120 mL of formula or breast-feeding. The new dose strength approval means that PERTZYE will now be available in three dosing options, providing for improved dosing options from infancy through adulthood.
“Together with Chiesi USA, we are excited to offer an FDA approved therapy for enzyme delivery for the smallest CF patients,” said Tibor Sipos, Ph.D., President and Chief Scientific Officer, Digestive Care, Inc. “Cystic fibrosis is a complex condition for anyone and the digestive challenges patients face are compounded in the infant stage due to dosing needs, infant size and the required mode of delivery, which also plays a role in the infant’s ability to properly benefit from the medicine.”
To support administration to infants, the 4,000 lipase units capsule features a reduced microsphere size ranging from 0.8 – 1.4 mm in diameter. This is in contrast to the 8,000 and 16,000 lipase units capsules, which contain microspheres in the range of 0.8 – 2.2 mm in diameter. The largest microspheres in the 4,000 lipase units capsule are approximately 35 percent smaller than the largest microspheres in the 8,000 and 16,000 lipase units capsules.
“Chiesi USA is committed to delivering therapeutic treatment options that meet the unique health needs of people with cystic fibrosis,” said Alan Roberts, Senior Vice President of Scientific Affairs at Chiesi USA, Inc. “We continue to work to expand treatment options in order to fill unmet needs, and our partnership with Digestive Care, Inc. is one of the ways that we bring innovative solutions to CF patients.”
In addition, Chiesi USA serves CF patients’ unique health needs with the Chiesi CareDirect program, a comprehensive patient program that can provide patients with prescription access, financial assistance, 1-on-1 support, and much more.
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