WASHINGTON (Reuters) - Bristol-Myers Squibb Co.'s. experimental drug to treat chronic hepatitis B infection showed benefits and improved liver problems, U.S. regulatory staff said in documents released on Thursday.
But Food and Drug Administration reviewers also expressed concerns over possible long-term resistance to the drug and questioned whether it posed a cancer risk.
The documents were released ahead of a panel meeting with outside experts on Friday to discuss whether the FDA should approve the drug. The agency usually, but not always, takes its panelists' advice.
Clinical trials and related studies showed the drug, known by its chemical name entecavir, "effectively reduces the (hepatitis B) viral burden," the reviewers said.
Studies also showed a number of other benefits in patients taking the drug for 48 weeks, including few major interactions with other drugs and easily adjusted doses, they said.
For more information: visit http://www.reuters.com/newsArticle.jhtml?type=healthNews&storyID=7866214
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