Allergan plc announced this week the positive opinion from the Committee for Medicinal Products for Human Use (CHMP) for ENZEPI, a new treatment for exocrine pancreatic insufficiency (EPI).
"Receiving the positive opinion for ENZEPI is a key milestone to bringing this new therapy to EPI patients across the Europe Union," Allergan EVP and President of R&D David Nicholson said. "Working to bring ENZEPI to European patients underscores our ongoing commitment to being a preferred partner to the gastrointestinal (GI) specialty areas and we are now actively looking to bring additional treatments and therapies to GI and cystic fibrosis specialists."
The pancreatic enzyme replacement therapy (PERT) assists patients with EPI due to cystic fibrosis, chronic pancreatitis or pancreatic cancer to digest their food. ENZEPI contains digestive enzymes necessary for the body metabolize fats, proteins and sugars. The treatment prevents malnourishment.
"ENZEPI has undergone extensive testing and offers accurate dosing which will give physicians confidence that they are prescribing the correct dose for their patients," University of Sheffield Consultant Paediatric Gastroenterologist Professor Christopher Taylor said. "It's very encouraging to see that ENZEPI has received a positive opinion from the CHMP as this means that once it receives a Marketing Authorization, patients and physicians will have another enzyme replacement therapy to choose from."
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