A Food and Drug Administration panel gave a positive recommendation to a gastrointestinal treatment co-developed by GSK giving the drug the inside track to U.S. regulatory approval.
The FDA panel said the benefits of the drug Entereg (Alvimopan), co-developed by Glaxo and Adolor Corp of Pennsylvania, outweigh its risks. The drug treats a condition called post-operative ileus, in which the gastrointestinal system doesn't function properly after bowel surgery.
The condition, which annually afflicts hundreds of thousands of patients, is characterized by constipation and other gastrointestinal dysfunction.
The full FDA is scheduled to make a final decision on Entereg by Feb. 10. The agency is not bound to follow the recommendations of its panels, though it typically does.
The agency might extend its review period, however, because the panel on Wednesday said Adolor needs to come up with a better plan for ensuring that patients don't take the drug on a long-term basis. Safety data show that the drug can be dangerous to the cardiovascular system in the long term, the panel said.
