The US Food and Drug Administration has given the green light to Johnson & Johnson’s Pancreaze for patients unable to digest and absorb food because they lack the necessary pancreatic enzymes.

Regulators have given clearance to Pancreaze (pancrelipase) delayed-release capsules for the treatment of exocrine pancreatic insufficiency due to cystic fibrosis or other conditions, which can leave patients unable to digest essential substances such as fats, proteins and sugars.

While Pancreaze’s predecessor Pancrease MT has been available across the pond since the 1980s from McNeil Pediatrics, a Division of Ortho-McNeil-Janssen Pharmaceuticals, the FDA decided in 2004 that all pancreatic enzyme products be made available by prescription only and seek approval via the new drug application channel in order to standardise manufacturing procedures and enzyme activity.

Consequently, J&J carried out a set of new clinical trials in support of its NDA for the product, designed to demonstrate its efficacy and safety in infants, children and adults with cystic fibrosis, and changed the drug’s name to conform to regulatory guidance for naming new products.

Pancreaze should be available in pharmacies in the next few months, the drugmaker said.