I have to compliment the folks at Vivus, they did a great job. Good enough to convince the Advisory Committee to recommend approval. The big question is whether they convinced the FDA. We’ll find out in a couple of months.
The AdComm does require a comment though. If I had heard the commentary from the AdComm members without knowing their vote or the overall vote, I would have thought the overall outcome would have been negative. Almost everyone of them expressed reservations about the CV signals and a concern about the teratogenicity. They used words like “trepidation”, “inconclusive”, “difficult decision”, “reservations” and the “risk is real”. And those were the panelists who voted YES. Most interesting were a couple that deserve noting. Regarding benefit risk, one panelist noted that because the drug is not 100% effective and presumably because those who will respond are not predictable, there will be patients who have the risk but not the benefit. The most unusual comment from a YES voter who had reservations about the teratogenic potential was “the baby gets no vote”. Dr. Lauer seemed to reflect my opinion best. He viewed the results as surrogate outcomes…based on hopes not data and reminded everyone of previous similar enthusiasm for antiarrythmics that looked good but killed people.
It will be interesting to see which words resonate with FDA, the YES votes or the reservations.