Digestive Care, Inc. Announces FDA Approval of a 24,000 USP Lipase Units Capsule of PERTZYE® (pancrelipase) Delayed Release Capsules to Treat Exocrine Pancreatic Insufficiency (EPI) Due to Cystic Fibrosis and Other Conditions
BETHLEHEM, Pa., July 14, 2017 — Digestive Care, Inc. (DCI) and its marketing partner to support the U.S. cystic fibrosis community, Chiesi, today announced U.S. Food and Drug Administration (FDA) approval of PERTZYE® (pancrelipase) in a 24,000 USP lipase units capsule. The newly available dosing strength caters specifically to children over 12 months of age and adults, which may allow for consumption of fewer capsules to reach the needed weight- based dose when compared to the other PERTZYE capsule sizes.
"Along with our partner, Chiesi, we feel it is important to offer options for enzyme delivery to those with EPI due to CF," said Tibor Sipos, Ph.D., President and Chief Scientific Officer, Digestive Care, Inc. "This is a complex condition for both caregivers and patients and we feel it is our responsibility to offer therapeutic solutions that may meet their needs."
The microsphere size of the 24,000 USP lipase units capsule ranges from 0.8 - 2.2 mm in diameter. For some patients, the larger capsule size may help to reduce the number of capsules needed to achieve the needed weight-based dose of PERTZYE when compared to the other PERTZYE capsule sizes.
"CF is a complex condition and each patient is unique; we are committed to delivering therapeutic treatment options," said Alan Roberts, Senior Vice President of Scientific Affairs at Chiesi.
Chiesi 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. For more information, please visit www.pertzyecf.com/savings-support/chiesi-caredirect/.
ABOUT PERTZYE (pancrelipase) DELAYED-RELEASE CAPSULES
PERTZYE® (pancrelipase) is indicated for the treatment of exocrine pancreatic insufficiency due to cystic fibrosis or other conditions.
IMPORTANT SAFETY INFORMATION ABOUT PERTZYE
Fibrosing colonopathy is associated with high-dose use of pancreatic enzyme replacement. Exercise caution when doses of PERTZYE exceed 2,500 lipase units/kg body weight per meal (or greater than 10,000 lipase units/kg body weight per day).
To avoid irritation of oral mucosa, do not chew PERTZYE or retain in the mouth. Hyperuricemia may develop. Consider monitoring uric acid levels in patients with hyperuricemia, gout, or renal impairment.
There is theoretical risk of viral transmission with all pancreatic enzyme products including PERTZYE.
Exercise caution when administering pancrelipase to a patient with a known allergy to proteins of porcine origin.
Most common adverse reactions (≥10%) are: diarrhea, dyspepsia, and cough.
PERTZYE® full Prescribing Information and Medication Guide are available at www.pertzyecf.com.
PERTZYE® (pancrelipase) is owned by Digestive Care, Inc. and is licensed to Chiesi USA for sales and marketing purposes in the United States.
About Digestive Care, Inc.
Digestive Care, Inc., headquartered in Bethlehem, PA, is a fully integrated pharmaceutical company, founded in 1990, dedicated to developing unique pharmaceutical products to alleviate complications and symptoms of gastrointestinal disorders. For more information, visit www.digestivecare.com.
Chiesi USA, Inc.
Chiesi USA, Inc., headquartered in Cary, N.C., is a specialty pharmaceutical company focused on commercializing products for the hospital and adjacent specialty markets. Key elements of the Company's strategy are to focus its commercial and development efforts in the hospital and adjacent specialty product sector within the U.S. pharmaceutical marketplace; continue to seek opportunities to acquire companies, marketed or registration-stage products and late-stage development products that fit within the Company's focus areas; and generate revenues by marketing approved generic products through the Company's wholly-owned subsidiary, Aristos Pharmaceuticals, Inc. Chiesi USA, Inc. is a wholly-owned subsidiary of Chiesi Farmaceutici S.p.A. For more information, visit www.chiesiusa.com.
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