The Brussels-based company is one of several pharma companies forced to meet US Food and Drug Administration (FDA) requirements brought in in April 2004 where manufacturers of pancreatic insufficiency products needed to have the drugs approved by the agency before April 2008 in order for the drugs to stay on the market.
Solvay spokesman Roger Bickerstaffe told US-PharmaTechnologist.com the approvable letter received in regards to the company's New Drug Application (NDA) for the updated Creon (pancrelipase delayed-release capsules) formulation had been expected and the company believed it was "still on path" to meet the approval deadline next year.
The new formulation was based on changes in the manufacturing process which would standardize the drug, which was a treatment for pancreatic exocrine insufficiency often associated with cystic fibrosis and chronic pancreatitis.
In its approvable letter to Solvay, the FDA stated that the company would need to provide additional clinical data.
Solvay is already undergoing clinical trials of the new formulation and would submit this information, Bickerstaffe said.
The FDA also requested Chemistry, Manufacturing and Controls (CMC) information, such as details on testing controls.
Bickerstaffe said the company would be in discussion with the FDA on how best to meet the requests.
Solvay chief executive and president Laurence Downey said in a statement: "We are confident that our ongoing clinical work that was initiated prior to receiving this letter will satisfy the FDA's request.
Creon helps meet a critical medical need for thousands of patients who suffer from cystic fibrosis and pancreatic insufficiency and we will continue to work with the agency to gain approval for this life-sustaining drug."
The currently marketed Creon has been available in the US for 20 years, but would be taken off the market once the improved formulation was approved.
Pancreatic extract products have a long history of use, some preceding the US Federal Food, Drug, and Cosmetic Act of 1938.
More than three dozen different products are currently marketed.
In April 2004 the FDA decided to require approval of NDAs for all pancreatic extract drug products after data showed substantial variations in drug potency among marketed products thereby affecting the safety and effectiveness of the drugs.
Other pancreatic insufficiency drugs that contain pancrelipase are Cotazym from Organon, Lipram from Global Pharmaceuticals, Viokase from Scandiphrm and Pancrecarb from Digestive Care.
Generic pancrelipase tablets and capsules are not available.
Creon, which is manufactured for the US market in Germany and packaged in the US, posted €191m ($257.6m) in global sales last year.