An FDA advisory panel unanimously decided to show Debiovision the door after deciding that an experimental drug it was proposing lacked the data it needed to prove the therapy stopped esophageal bleeding. Salix Pharmaceuticals has the U.S. marketing rights to the drug.
By a vote of 14 to 0 the experts concluded that Debiovision had not made the case that Sanvar's benefits outweighed its risks. Committee Chairwoman Dr. Lin Chang concluded that one study appeared to demonstrate a small level of improvement but that data from other studies was hard to interpret. One market analyst had estimated that Sanvar was likely to reap about $50 million in sales each year, if approved.
The FDA had concluded back in 2004 that the drug was approvable but that more data was needed before it could issue an approval.
- read the report [1] from Reuters
Links:
[1] http://www.reuters.com/article/latestCrisis/idUSN19446525