FDA approvs infant-specific dose of Pertzye delayed-release capsules to treat EPI due to cystic fibrosis
The new formulation will be offered in 4,000 lipase units capsule.
Digestive Care, Inc. (DCI) and its marketing partner in the US cystic fibrosis community, Chiesi USA, Inc., have announced 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, 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 to 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 to 2.2 mm in diameter. The largest microspheres in the 4,000 lipase units capsule are approximately 35% 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."
Related News
-
News Eli Lilly gets ready to launch five new drugs in 2023
Eli Lilly, the American pharmaceutical company (IN, USA) are gearing up for a big year ahead, with hopes to launch five new drugs and capitalise on growing obesity and Alzheimer’s disease markets. -
News Amgen buys Horizon for $27.8 billion in bold step into the rare disease market
Amgen Inc buys pharmaceutical company Horizon Therapeutics in a multibillion-dollar deal, in hopes to capitalise on it's portfolio of drugs in the highly sort after rare disease market. -
News Pharma Supply Chain People Moves
The latest appointments and promotions across the pharmaceutical supply chain. -
News Merck to donate new Ebola vaccine to defend against outbreaks in Uganda
Pharmaceutical giant Merck has announced they will be speeding up the processing of a new vaccine against the latest strain of the Ebola virus, to be donated to a global non-profit organisation for distribution -
News CPHI Podcast Series: Driving innovation with pharmaceutical startups
The latest episode in the CPHI Podcast Series explores how startups are driving innovation by taking high-risk approaches and doing business with greater agility. -
News Greener and efficient processes: Quaternary Ammonium Salts
Quaternary Ammonium Salts play a crucial part in Organic Chemistry processes at many major industries. Discover why.
-
News Biosimilars save patients $11B annually, but barriers to adoption remain in US market
Biosimilars introduce competition into the biologics market, driving down prices and increasing patient access. -
News WHO recommends use of two monoclonal antibody treatments against Ebola
The health body recommended use of treatments by Regeneron and Ridgeback Bio
Position your company at the heart of the global Pharma industry with a CPHI Online membership
-
Your products and solutions visible to thousands of visitors within the largest Pharma marketplace
-
Generate high-quality, engaged leads for your business, all year round
-
Promote your business as the industry’s thought-leader by hosting your reports, brochures and videos within your profile
-
Your company’s profile boosted at all participating CPHI events
-
An easy-to-use platform with a detailed dashboard showing your leads and performance