Solvay Seiyaku Submits NDA For SA-001 In Japan

Solvay Seiyaku K K, the Japanese entity of Solvay Pharmaceuticals, has submitted a New Drug Application (NDA) for SA-001, a pancreatic enzyme replacement therapy agent for pancreatic exocrine insufficiency (API name: Pancrelipase) in Japan. The company has developed SA-001 in co-operation with Eisai.

The company claims that SA-001 agent is a high performance, acid resistant enteric-coated pancreatic enzyme obtained by formulating highly purified pancrelipase with a proprietary technology. It is marketed as Creon/Kreon in 75 countries outside Japan including the US, the UK and Germany.

Creon/Kreon is an enzyme replacement therapy for pancreatic exocrine insufficiency due to cystic fibrosis, chronic pancreatitis, and pancreatectomy and other conditions. After obtaining its manufacturing and marketing authorisation for the agent, distribution in Japan will be conducted by Eisai. Solvay Seiyaku retains co-promotion rights with Eisai.

Reportedly, the agent improved the difference of fat absorption ratio calculated from fat intake and discharged fat in stool before and after administration in its clinical study in patients with pancreatic exocrine insufficiency due to chronic pancreatitis or pancreatectomy, conducted in Japan.

Furthermore, the agent showed positive improvements of the nutrition evaluation scale in its long term study. Also, the agent showed important improvements of fat absorption ratio and nutrition evaluation scale in a clinical study in patients with pancreatic exocrine insufficiency caused by cystic fibrosis, said the company.