Allergan receives CHMP backing for EU approval of Enzepi

Allergan has announced that the European Committee for Medicinal Products for Human Use (CHMP) has recommended its drug Enzepi for EU approval.

The European Medicines Agency committee has endorsed the pancreatic enzyme replacement therapy (PERT) for use in patients with exocrine pancreatic insufficiency due to cystic fibrosis or other conditions.

Enzepi has been specifically formulated to meet 100 percent of the label-claimed lipase enzyme activity, in line with the CHMP guidelines, ensuring no overfill and guaranteeing accuracy and consistency of dosing.

In clinical trials, it has demonstrated comparable efficacy and tolerability to an existing PERT formulation. The drug will be available in four strengths to facilitate individualised titration of dosage and a tailored treatment for each patient.

David Nicholson, executive vice-president and president of research and development at Allergan, said: "Working to bring Enzepi to European patients underscores our ongoing commitment to being a preferred partner to the gastrointestinal specialty areas and we are now actively looking to bring additional treatments and therapies to gastrointestinal and cystic fibrosis specialists."

If approved, Allergan expects the product to be launched across Europe early next year.