Allergan Receives CHMP Positive Opinion For ENZEPI For Patients With EPI

(RTTNews) - Allergan plc (AGN) said that the Committee for Medicinal Products for Human Use or CHMP has adopted a Positive Opinion for the Marketing Authorisation of ENZEPI or pancrelipase in the European Union.

ENZEPI is a pancreatic enzyme replacement therapy or PERT for patients with exocrine pancreatic insufficiency or EPI due to cystic fibrosis or other conditions (e.g. chronic pancreatitis, post pancreatectomy or pancreatic cancer).

ENZEPI is specifically formulated to meet 100 percent of the label-claimed lipase enzyme activity, in line with the CHMP guidelines.

Patients with EPI cannot digest food normally because there is a deficiency in their exocrine pancreatic enzymes. ENZEPI contains a defined amount of digestive enzymes including lipases, proteases and amylases which are required by the body to metabolise fats, proteins and sugars from food.

Without these enzymes, patients with EPI are less able to absorb essential nutrients from food and can become malnourished. Effective management of EPI includes life-long pancreatic enzyme replacement therapy (PERT), lifestyle and dietary modifications and vitamin and nutrient supplements.

In a clinical trial, ENZEPI demonstrated comparable efficacy and tolerability to an existing PERT formulation.6 ENZEPI will be available in four strengths2 to allow for individualised titration of dosage and a tailored treatment for each patient. ENZEPI has been purified using an additional treatment step designed to inactivate viruses and thus increase the level of viral safety.