Allergan Gets Positive Opinion From EU's CHMP For Its ENZEPI

Allergan plc AGN revealed that the Committee for Medicinal Products for Human Use (CHMP) has adopted a Positive Opinion for the Marketing Authorisation of ENZEPI (pancrelipase) in the European Union. According to the company, 1 ENZEPI was a pancreatic enzyme replacement therapy (PERT) for patients with exocrine pancreatic insufficiency (EPI) due to cystic fibrosis or other conditions like chronic pancreatitis, post pancreatectomy or pancreatic cancer.

Similarly, Allergan said that 2 ENZEPI® was particularly formulated to meet 100 percent of the label-claimed lipase enzyme activity, in line with the CHMP guidelines.3,4.

Allergan's EVP and President of R&D, David Nicholson, commented that "Receiving the positive opinion for ENZEPI® is a key milestone to bringing this new therapy to EPI patients across the Europe 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 GI and cystic fibrosis specialists."

University of Sheffield's Consultant Paediatric Gastroentroenterologist, Professor Christopher Taylor, also remarked that "ENZEPI® has undergone extensive testing and offers accurate dosing which will give physicians confidence that they are prescribing the correct dose for their patients. 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 Authorisation, patients and physicians will have another enzyme replacement therapy to choose from."

During the clinical trial, ENZEPI® demonstrated comparable efficacy, as well as, tolerability to an existing PERT formulation.6 ENZEPI® would be available in four strengths2 to allow for individualized titration of dosage and a tailored treatment for each patient.