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Allergan eyes early 2017 European launch for Enzepi

CHMP backs the enzyme replacement therapy's approval

AllerganAllergan's Enzepi (pancrelipase) has been recommended for European approval to treat exocrine pancreatic insufficiency (EPI) in patients with conditions such as cystic fibrosis.

The EMA's Committee for Medicinal Products for Human Use (CHMP) backed the use of the pancreatic enzyme replacement therapy (PERT) for use by infants, children and adults.

EPI is a chronic condition in which patients cannot digest food normally due to inadequate delivery of pancreatic digestive enzymes to the intestine and so often results in malnutrition.

It is mostly associated with underlying conditions, such as cystic fibrosis and pancreatic cancer, with effective management involving life-long PERT, lifestyle and dietary modifications and nutrient supplements.

The CHMP's recommendation for Enzepi is likely to be translated into a full approval from the European Commission by August, at which point it will compete with Mylan's Creon in a number of European markets.

Allergan's president of research and development David Nicholson commented that CHMP's verdict was a “key milestone” in bringing another treatment option to patients in the EU.

He added: “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.”

Enzepi is already licensed in the US, where it is branded as Zenpep and competes against the likes of Creon and Johnson & Johnson's Pancreaze.

The drug is a pancreas powder containing multiple enzymes including lipases, proteases and amylases, which work to metabolise fats, proteins and sugars from food.

Enzepi will be available in four dosages of different strengths to allow for a treatment plan tailored to individual EPI patients.

Article by
Rebecca Clifford

3rd May 2016

From: Regulatory

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