Let’s not get too excited

Let’s not get too excited

Late last week an FDA panel voted 10 to 5 to approve canagliflozin, a new treatment for type 2 diabetes from Johnson and Johnson (NYSE:JNJ). Canagliflozin actually isn’t really a new treatment rather part of a new class of drugs, SGLT2 inhibitors. Nor is canagliflozin the first SGLT2 to go before the FDA, as Dapagliflozin from Bristol Myers Squibb (NYSE:BMY) and AstraZeneca (NYSE:AZN) has already been turned away by the FDA over cancer risk. It should also be noted that while this panel voted to approve canagliflozin several panel members, some who voted in the affirmative, voiced concerns over the drug’s safety profile.

Diabetic Investor has been somewhat surprised by the level of interest in this new class of drugs as several subscribers have wondered why we have not written more about this class. Well the truth is the people we talk with, notably diabetes researchers, endocrinologists and primary care physicians aren’t all that excited about this class and don’t believe this will turn out to be the next Januvia.  This is not to say they won’t prescribe the drug rather they will do what has become standard operating procedure for every new diabetes drug approved after the Avandia controversy, in that they will use it on a limited basis until they are completely comfortable before prescribing the drug to a wider portion of their patient population.

This is exactly what’s going on now with Bydureon™, now owned by Bristol.  It’s also what went on with Victoza® from Novo Nordisk when it first came on the market. The fact is, whether drug companies like it or not, the Avandia controversy continues to impact the market for new diabetes drug although the drug was withdrawn from the market.  The reality is the Avandia situation could not have been handled in a worse manner and that to this day there are several notable diabetes researchers who believe the drug got a bum deal.

It also doesn’t help any that Actos, also a TZD like Avandia, was found to show an increased incidence of bone fractures and this was after the drug was on the market for seven years. It also contrasts with Januvia’s profile which is relatively unblemished compared to other drugs that have either just come on the market or are in late stage development. And while Januvia has had no serious issues to date, the drug has undergone label changes and some have raised concerns over long term usage of the drug.

What everyone needs to come to grips with in this post-Avandia world is with a an ultra-conservative FDA ,a  litigious public and skeptical physicians it would take a near miracle for any new diabetes drug to become an instant blockbuster as Januvia did when it came to market. As Diabetic Investor has noted on more than one occasion, Januvia is the luckiest drug on the planet and owes much of its success not to how well the drug performs but rather to a series of events which basically created the perfect storm and boosted the drug to blockbuster status.

One has to wonder how that cardio crusader, Dr. Steven Nissen feels about the monster he created. Like Dr. Frankenstein he may have started with noble goals but those goals were quickly perverted and just as at the monster was let loose on an unsuspecting village creating havoc so too has the fallout from the Avandia controversy. The fact is the diabetes drug landscape has forever changed and not for the better.  Sure hope the good doctor is happy.