Ireland-based pharmaceutical company Allergan has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP), for the marketing authorisation of ENZEPI (pancrelipase) in the European Union (EU).
ENZEPI is a pancreatic enzyme replacement therapy (PERT) for patients suffering from exocrine pancreatic insufficiency (EPI).
EPI is largely caused due to cystic fibrosis or other conditions such as post pancreatectomy, chronic pancreatitis or pancreatic cancer.
The drug has been particulary formulated to address 100% of the label-claimed lipase enzyme activity, which follows the CHMP guidelines.
Allergan Research and Development EVP and president David Nicholson said: "Receiving the positive opinion for ENZEPI is a key milestone to bringing this new therapy to EPI patients across the European Union.
"Working to bring ENZEPI to European patients underscores our ongoing commitment to being a preferred partner to the gastro-intestinal (GI) specialty areas, and we are now actively looking to bring additional treatments and therapies to both GI and cystic fibrosis specialists."
People afflicted with EPI suffer from a deficiency in their exocrine pancreatic enzymes that do not allow them to digest food normally.
ENZEPI comprises a specific amount of digestive enzymes including amylases, lipases and proteases, which help the body to metabolise sugars, fats and proteins from food, thereby protecting it from malnutrition.
EPI can be significantly managed through life-long pancreatic enzyme replacement therapy (PERT), vitamin and nutrient supplements, as well as lifestyle and dietary improvements.
ENZEPI will be available in four strengths to enable individualised titration of dosage and a customised treatment for each patient.
It has also been purified using an additional treatment step designed to inactivate viruses, thereby enhancing the level of viral safety.
ENZEPI is the first PERT to be analysed through the Centralised Procedure.