Solvay files for pancrelipase approval in Japan
This article was originally published in Scrip
Solvay has filed for the approval of the pancreatic enzyme replacement therapy pancrelipase (SA-001) in Japan. The product was co-developed for this market with Eisai, which will distribute it should it be approved.
The enteric-coated, delayed release microsphere formulation is already marketed in more than 70 countries as Creon/Kreon, and is indicated for pancreatic exocrine insufficiency related to disorders such as cystic fibrosis and chronic pancreatitis, or pancreatectomy (surgical removal of the pancreas). Solvay Pharmaceuticals' Japanese subsidiary, Solvay Seiyaku, has retained co-promotion rights as part of the tie-up with Eisai.
The product replaces enzymes such as amylase, trypsin and lipase normally produced by the pancreas and which aid in the digestive process, particularly the breakdown of fat. A Japanese clinical trial in patients with pancreatic exocrine insufficiency due to chronic pancreatitis or pancreatectomy showed a statistically significant improvement in the percentage of fat absorption relative to dietary fat intake compared with placebo, as well as other nutritional improvements, Eisai said. Improvements were also seen in patients with pancreatic insufficiency related to cystic fibrosis.
Solvay's pancrelipase was the first product to receive formal approval under new US guidelines for pancreatic enzyme products, in May last year.