Never underestimate Novo

Never underestimate Novo

In what we can only call a complete shocker the FDA voted 16-0 in favor for approving Xultophy the long-acting insulin GLP-1 combination from Novo Nordisk (NYSE: NVO). Obviously Novo is pleased with the results as are the folks in France as Sanofi (NYSE: SNY) is next on the docket with their combo product LixiLan. Still given the strong reservations the FDA had surrounding study design we are shocked not just that the panel voted to approve the drug but did so unanimously.

Our gut tells us the panel as it so often does when it comes to diabetes felt that it’s better to have more rather than less treatment options available for patients with Type 2 diabetes.  Although the study data may have been less than perfect the panel members likely reasoned that the drug was effective and there were no serious adverse events associated with its usage.

Frankly Diabetic Investor should have known better as Novo has been through this before and in spite of issues noted in the meeting documents they manage to get the nod. This is exactly what happened when Victoza went before an FDA panel years ago when everyone thought a previously unknown issue with thyroid cancer would derail the drug.

Like we said earlier in the day these panel meetings are a lot like the wacky world where anything can and usually does happen even when it makes no sense whatsoever. In this case Diabetic Investor was 100% wrong earlier in the day. It does happen sometimes.