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news.Eurand has announced that the European Medicines Evaluation Agency confirmed that a marketing application for Zentase is eligible for centralized marketing authorization submission in the EU.
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Eurand plans to file a marketing authorization application for EUR-1008 (Zentase), the company’s pancreatic enzyme product candidate, through a centralized procedure, the approval of which would allow market access to 27 EU member states.
Eurand’s lead product candidate, Zentase (EUR-1008), is an innovative pancreatic enzyme replacement therapy which is being developed to treat pancreatic insufficiency, a condition associated with cystic fibrosis, chronic pancreatitis and other diseases.