Shares in Solvay have been given a boost on news that US regulators have formally issued a green light for the Belgian drugmaker’s pancreatic enzyme drug Creon, making it the first such product to be approved under new guidelines for this class of drugs.

The group’s stock closed up nearly 3% after the US Food and Drug Administration gave its seal of approval to Creon (pancrelipase) for the treatment of exocrine pancreatic insufficiency in patients with cystic fibrosis or other diseases. The condition stems from a deficiency in the production/secretion of pancreatic enzymes crucial for digesting nutrients in food and, if left untreated, can cause causes malnutrition and even death.

Pancreatic enzyme drugs have been used to treat the disorder long before current FDA regulatory requirements came into force, and have so could be sold without a formal New Drug Application approval. Back in 2004, however, regulators decided that all manufacturers must submit NDAs in order for them to continue to be marketed, so that, by April 2010, all pancreatic enzymes will be manufactured under the new guidelines.

Creon’s approval was based on data from a randomised, double-blind, placebo-controlled crossover study with 32 patients with CF, which met its endpoint by showing that patients taking the drug were able to absorb more fat from their diet than those given a placebo, as measured by the coefficient of fat absorption (CFA). The mean CFA during treatment with Creon was 89% compared to 49% in the control group, clearly demonstrating its effectiveness.

"As the first and only product in the pancreatic enzyme class to be FDA-approved under the new guidelines, Creon helps meet a critical need for thousands of patients with EPI," commented Stephen Hill, President of Solvay Pharmaceuticals Inc.