The early betting line

The early betting line

At this very moment the FDA is conducting the panel meeting for Xultophy the long-acting insulin GLP-1 combination from Novo Nordisk (NYSE: NVO). Tomorrow the same panel will meet to discuss LixiLan, Sanofi (NYSE: SNY) combination product. Now before we go any further let us stress that these observations are based on what we have heard so far and a more detailed review of the meeting materials.

That being said we believe the panel will vote NOT to approve either drug. It seems the FDA isn’t thrilled with the way the clinical trials for either drug were designed and conducted. Simply put the FDA believes that both Novo and Sanofi stacked the deck in favor of their combo products. Additionally, they believe neither Novo or Sanofi were realistic as to how these drugs would be used in the real world.

The real question here is; are patients better off using these drugs individually rather in combination. Will patients ultimately experience better control using a combination of long acting insulin and GLP-1 or would outcomes better using just a long acting insulin or GLP-1.

Here is where history may be working against Novo and Sanofi. It is well known that when used as intended both long acting insulin or a GLP-1 are very effective therapy options. The benefits and side effects of both therapy options are well known. Therefore, both Novo and Sanofi must prove that their combination products are not equal too but better than either product used by itself. This is high hurdle to overcome, a hurdle that has become higher given the concerns the FDA has expressed over trial design.

Given that the meeting still has a long way to go and a vote likely won’t come until late in the afternoon it’s possible we are 100% wrong. Like everything else in this wacky world what looks obvious isn’t always obvious. Diabetic Investor has been to many panel meetings where it looked like one result would occur only to see the opposite result end up happening.

Yet even with a yes vote one has to wonder how either product would perform in the marketplace. As we noted yesterday we don’t see physicians embracing either product. Nor do we see payors giving either drug favorable formulary position or premium reimbursement. The fact is payors and the FDA know that patients with Type 2 diabetes have multiple therapy options which when used as intended are very effective. Or put another way is either combo product really that much better than the options already available.

Like we said it’s still early but right now we wouldn’t bet on either drug no matter what the vote is looking very good when this is over.