U. S. advisory panel on Wednesday dismissed Eli Lilly & Co (LLY. N) request to approve its drug liprotamase (Sollpura), a pancreatic enzyme product for cystic fibrosis and other diseases that cause pancreatic insufficiency.
The FDA's Gastrointestinal Drugs Advisory Committee voted 7-4, concluding that the drug fails to offer sufficient evidence that shows that it poses a better efficacy rate compared to other drugs already floating in the market.
However, the panelists asked the company to present more data.
In addition, it is reported that one panelist ruled liprotamase as a strict no for use in patients suffering from cystic fibrosis, chronic pancreatitis, and pancreatic cancer -- diseases which compromise pancreatic function, resulting in severely impaired secretion of the digestive enzymes.
Patients suffering with exocrine pancreatic insufficiency face lipids absorption problems, thereby causing weight loss and severe malnutrition.
"I was not convinced that the data showed meaningful efficacy for this agent although it's obviously greatly needed", Panel chairman and University of Maryland medical professor Jean-Pierre Raufman, echoing other panelists, was quoted as saying.
It is reported that the FDA is not required to stick on to the advice of its advisory panels, unlike it does.












