Bristol-Myers Squibbs' drug, ONGLYZA (saxagliptin) cleared the first hurdle on its way to FDA approval. The FDA Advisory Panel gave the thumbs up to ONGLYZA, but recommended long-term studies be done to further confirm the drug is "heart healthy". New regulations are in place following the infamous "meta-analysis" of Dr. Nissen, in 2007, showing AVANDIA increased heart disease risk. of 2007.
The FDA panel voted 10 to 2 that the companies' data do not suggest the drug hastens heart attack, stroke and other problems. But panelists voted unanimously that the company should be required to conduct a long-term study in high-risk patients, including the elderly, to assure the drug's heart safety.
"Our primary goal is to protect the patient, and I just don't think there's enough data in the studies to be absolutely certain that there is no risk," said panel chairman Kenneth Burman of Washington Hospital Center.
The FDA is not required to follow the group's recommendation, though it normally does. A final decision is expected by April 30.
Interesting. These FDA Advisory Panel decisions, on new diabetes therapies, used to include a statement or two about how effective the drug is regarding the treatment of diabetes!