Biotech Values

[biomaven0]

The Qnexa safety data didn't seem to merit the overwhelming panel support for the drug. Was the panels vote swayed by the data at hand?

One of the panelists said something to the effect of: "We know a lot more about this drug than we do about most NDAs." The fact that both components have been widely used over decades (so literally millions of patient years) means that the chances of some weird drug reaction (think liver tox) is much lower than for the typical new drug.

I personally didn't see anything troubling about the safety data at all except for the known cleft issue. With blood pressure dropping, HDL increasing and diabetes conversion positively impacted I wouldn't be surprised if the cardiac events safety study shows superiority, not just non-inferiority.

Peter