When Bristol-Myers Squibb disclosed that it was suspending dosing of one of its hepatitis C drugs BMS-986094 because of safety issues, I pointed out that investors should be worried about it being a class effect extending into other nucleotide-based hepatitis C drugs.
Apparently, what they needed to be concerned about was the Food and Drug Administration being worried about a class effect. The agency put Idenix Pharmaceuticals'
As best I can tell, this is simply guilt by association. There's no evidence that IDX184 has the same cardiac issues that were observed with BMS-986094. Nine patients in an ongoing phase 2b clinical trial reported shortness of breath -- known medically as dyspnea -- but the patients in the trial were also given pegylated interferon and ribavirin, which is known to cause dyspnea. Idenix is planning on giving the patients echocardiograms to check for heart issues.
The problem with clinical holds is that it's usually unclear how long it'll take to convince the FDA that there isn't a problem. Idenix doesn't know exactly what the FDA wants, and even after it gains clarity, there are no guarantees that will be the end of it. Scientific data often land in a gray area and spur further questions rather than definitively answering the original one.
Meanwhile, what's bad for nucleotide-based drugs is good for companies such as Abbott Labs