Novo ups the ante
Today at the Canadian Diabetes Association Congress in Montreal Novo Nordisk (NYSE:NVO) released more detailed data from the LEAD™6 study that compared liraglutide to Byetta from Amylin (NASDAQ:AMLN). The 26 week study included 464 type 2 patients randomized to receive either 1.8 mg of liraglutide once daily or Byetta 10 ug twice daily, both as an add-on to their existing treatment of metformin and/or a sulphonylurea.
According to the results, shown in the table below, it appears that liraglutide outperformed Byetta.
| Liraglutide 1.8 mg QD + metformin and/or SU N=233 | Exenatide 10 μg, BID + metformin and/or SU N=231 |
Diabetes duration, years at baseline | 8.5 | 7.9 |
BMI, kg/m2 at baseline | 32.9 | 32.9 |
HbA1c, % at baseline | 8.2 | 8.1 |
Change in HbA1c % (SE) from baseline | ‑1.12* (0.08) | ‑0.79 (0.08) |
% HbA1c <7.0% | 54* | 43 |
% HbA1c ≤6.5% | 35* | 21 |
Weight change, kg from baseline | ‑3.24 | -2.87 |
% Change in HOMA-B from baseline | 32.1* | 2.7 |
Change FPG (fasting plasma glucose) mmol/L from baseline | -1.61* | -0.60 |
Minor hypoglycemic events/subject/year | 1.9* | 2.6 |
*P<0.05 | ||
Not surprisingly the most common adverse event associated with both liraglutide and Byetta was nausea. Nor is it surprising that percentage of patients reporting nausea in both groups fell the longer the patient was on the therapy.
Missing from the data released today was any mention of pancreatitis, which unfortunately is the key piece of information everyone is focusing on. In previous statements Novo has mentioned that like Byetta the incidence rate of pancreatitis for liraglutide patients is below the incidence rate of pancreatitis for diabetic patients in general.
Since the pancreatitis issue became public the dynamic of the GLP-1 market have changed dramatically. A strange twist of events when after the ADA conference this year it appeared GLP-1 therapy was set to take off. Study after study at the conference confirmed that besides providing excellent glycemic control, patients on GLP-1 therapy experienced weight loss and improved blood pressure scores. With an increasing amount of attention being paid to cardiovascular events and poorly controlled diabetes it looked as though GLP-1 therapy was the answer everyone was looking for.
The pancreatitis issue has changed all that. As Diabetic Investor has pointed out previously three key events will determine the future of GLP-1 therapy:
1. The Byetta Label Change
2. Novo’s FDA panel meeting
3. Submission of the once-a-week long acting version of Byetta to the FDA
As we have already seen with the Avandia controversy should the FDA demand a Black Box warning for Byetta, something Diabetic Investor views as unlikely, it’s practically game over for Amylin and a serious blow to liraglutide. Hopefully Amylin will provide some insight into how this process is proceeding when they announce earnings next Tuesday the 21st at 5pm EST.
Based on all available evidence and several interviews with respected researchers Diabetic Investor maintains our belief that the pancreatitis concern is overblown. However the FDA has boxed themselves into a corner and now must find a way to undo the damage already done. An almost impossible task as this information is in the public domain. At minimum the FDA should provide some context to their earlier action.
Diabetic Investor believes strongly that GLP-1 therapy offers the best hope for turning the tide of poor control for millions of patients with type 2 diabetes. We are also not blind to the fact that no therapy option is free from adverse events. Physicians and patients need to guidance prepared using evidence based medicine. Then and only then will the FDA regain the public’s trust.
