INDIANAPOLIS (AP) – Drugmaker Eli Lilly and Co. Inc. said a panel of federal health advisers voted against an experimental treatment designed to aid digestion in patients with cystic fibrosis and other diseases that affect the pancreas.
The Food and Drug Administration’s panel of gastrointestinal experts voted 7-4 against the effectiveness of the drug at an all-day meeting held in Silver Spring, Md. Panelists said Lilly should be required to conduct additional studies of the drug, known generically as liprotamase.
The FDA is not required to follow the advice of its panelists though it often does.
The drug is designed to treat exocrine pancreatic insufficiency – a shortage of a pancreatic enzyme that aids in digestion. The condition is usually seen in patients with cystic fibrosis or chronic pancreatitis or those who have undergone surgery to remove part of the pancreas. Indianapolis-based Lilly acquired the drug as part of its acquisition of Alnara last summer.
Public safety advocates argued Wednesday that Lilly’s drug is less effective than other pancreas treatments already on the market.
Lilly said in a statement it would work to address the concerns raised by the panel.
Like many other drugmakers, Lilly faces a wave of patent expirations in coming years that will dramatically shrink its revenue. Its top-selling product, the schizophrenia drug Zyprexa, loses patent protection later this year, exposing more than $4 billion in annual sales to generic competition. The patent on the company’s second best-seller, the antidepressant Cymbalta, loses protection in the next few years.
Date: January 12, 2011
Source: Associated Press
Filed Under: Drug Discovery