Question about the pre or post study (heart issue) about VVUS? Given the 20-2 advisory vote last week, what are the odds FDA will request a pre study from VVUS before the FDA decision on April? Or why would the FDA approve Qnexa and months later request a study about heart issues?
Let's say Qnexa gets approved on April 17th, and the company completes the post-approval study and there are significant side effects (heart issues), would the FDA at that time pull the product off the shelves?
I guess my question is, wouldn't the FDA request be prudent and request the study before approving a product that may have significant side effects?
I'm not bashing/pumping nor short/long, want to initiate position but still in the process
Thank you everyone for your reponse
The FDA report was written in a manner that it doesn't expect additional studies before approval. The political realities of pharma frustration and cost of care for the obese make it likely to see approval with continuing studies only.-Very long for years here.
I cut and paste from sumpsters
Obese, food lovers have far greater than 1.3% incidence of cardiac events. Bottom line, being fat is worse than almost anything, including smoking. I've sold 2/3 of my position and will buy back on a dip. All drugs have side effects. The potential risks of Qnexa don't even come close to outweighing the benefits. Fat people die young and cost the heath care system billions. The risk reward to them and to the investors is tremendous. All drugs have side effects. If you cant get it up you can take an erectile dysfunction drug. However, you will be able to have sex but risk going blind or having a hard on for 4 hours. Depressed people take anti depressants that increase their already heightened risk of blowing their brains out. Fat people have an enormous risk of stroke, MI, etc. This drug reduces that risk. Period.
Qnexa is the only drug that provided an average of 10% weight loss, an amount that is associated with improvement in obesity-related conditions. These include high blood pressure and type 2 diabetes, which were improved in patients that took qnexa for 2 years. The 2-year follow up study is what likely convinced the EMDAC to recommend drug approval.
The FDA is likkely also considering the potential impact of delaying approval of an effective weight loss drug for yet another 2-3 years, especially one that is composed of 2 drugs readily available. These two drugs are already being prescribed off-label, but are potentially given at a higher dose and with uncontrolled access to women of child-bearing potential.
this question was specifically discussed at adcom, and panel favor post-approval study.
fda panel has to weight risk of any side effect, with unmet need. in this case, there is not sufficient evidence of risk, to let patients with unmet need wait for this drug. hence, post-approval study.
Point taken and appreciate your opinion. I understand this is an unmet need, but what if the side effects outweigh the benefits? Wouldn't the FDA request pre-approval study just to make sure the product is safe? On the other side, I can also see this to be post-approval since the FDA had time ( and didn't though) to request pre-approval study and they haven't at this time, so why would they come next month or days before the FDA decision and say, oh we'd need a pre-approval study? not that they've done this before, but given all the time they had and never made it a requisite
The FDA was placed in a similar position with Orexigen's obesity drug that also received a positive Advisory Committee vote recommending the drug be approved, yet the FDA turned around and issued a CRL on the PDUFA date requesting a large cardiovascular study be conducted before the drug is approved.