Sometimes when something doesn’t make sense you can either scratch your head or take a closer to look to see if you perhaps missed something. We mention this as we just couldn’t understand why Novo Nordisk was studying the oral version of semaglutide to death. Why they weren’t aggressively getting this drug to the FDA.
At first, we chalked up this lackadaisical attitude to Novo being Novo. A company that based on their history has never meet a study they didn’t like. With the GLP-1 market continuing to grow and this being a potential blockbuster drug as it would be the first oral in the category, we figured there must be a reason for this methodical approach.
At first glance the drug seems poised to be a major hit. Control looks good there is the additional benefit of weight loss and it’s an oral while all the other GLP-1’s are injectable. Based on the data published to date there seems to be no major issues that would prevent this drug from being the hit Novo needs it to be.
Yet taking a closer look we discovered some issues which could prevent this drug from reaching its potential. The biggest issue is how the drug is dosed. Unlike most orals which are simple to dose this drug requires that the patient fast for a minimum of six hours before taking the drug. Additionally, the drug cannot be taken with too much water nor can the patient eat anything for a minimum of 30 minutes after taking the drug.
What’s a bigger problem is should the patient not follow this protocol the drug doesn’t work. Violate any of the three protocols outlined, fasting, using too much water or eating too soon and the drug flat out doesn’t work.
Now we suppose this strict dosing protocol could be covered by the physician and an argument can be made that patients are creators of habit, so this strict protocol could be a good thing. The physician could instruct the patient to take the drug each morning before they shower. The theory being that since the patient doesn’t eat while sleeping this covers the fasting requirement. The water level requirement can be covered fairly easily and by taking it before the morning shower covers the 30-minute waiting period.
We do however see some issues with this rather strict dosing protocol. First, the physician has to remember to explain the protocol. Second, the patient must comprehend and follow the protocol and finally as the late Al Mann used to say; “The more chances you give the patient to screw up the more likely it is they will screw up.”
Our other concern is how Novo will deal with the FDA who will likely conduct a panel before approving the drug. Based on their history Novo has a nasty way of over complicating things. Although Victoza has been a major hit for Novo the company almost screwed the pooch when that drug faced its FDA panel. Just as they are doing with this drug Novo studied Victoza to death and some these studies detected a possible link between Victoza and thyroid cancer.
Now this link wasn’t a major issue and while no cancer is a good thing thyroid cancer is slow growing and rarely fatal. However, Novo spent an excessive amount of time covering this issue during the panel meeting making it seem as though what was a minor issue was a major issue. Thankfully the panel used common sense and voted to approve the drug.
The question is will history repeat itself when this drug finally gets submitted to the FDA. With the all the studies being done will the company discover a minor issue which they will turn into a major issue. Listen the strict dosing protocol is tough enough and they don’t need anything else complicating their lives. Given how things are going Novo desperately needs this drug to be a hit. Yet we can’t help but believe Novo will be Novo and overcomplicate things.
Diabetic Investor is also looking into how the all this study data is being analyzed as it seems the FDA is requiring two different statistical analysis. Now we aren’t sure why the FDA has asked for this, but we are taking a closer look.
The reality here is this drug which at first glance seemed destine to be a blockbuster may or may not reach that level. Based on what we know we still believe the drug will be approved by the FDA. This of course assumes there is nothing that comes up from the two different statistical analysis. Yet the strict dosing protocol is another cause for concern.
So, what seemed like a slam dunk is no slam dunk at all. Unfortunately, the closer we look the less we like what we see.