Novo releases Liraglutide Study Data
This morning Novo Nordisk (NYSE:NVO) announced the results of two studies involving Liraglutide, their once-daily human GLP-1 analogue. The two studies are part of the LEAD® (Liraglutide Effect and Action in Diabetes) program which consisted of 2,132 patients.
In LEAD 1 Liraglutide was compared to rosiglitazone, in LEAD 2 after a run-in period to reach the maximum dose of metformin, patients were randomized to treatment with placebo, glimepiride or Liraglutide. In both trials the average HbA1c at beginning was just below 8.5% with an average body weight of 80 to 90 kg.
Both studies showed Liraglutide to be effective in lowering A1c, with more than 50% of patients reaching goal (Goal defined as <7%) in LEAD 1 and 40% in LEAD 2. When used as an add on therapy in LEAD 2 65% of patients reached target A1c levels. In both studies patients using Liraglutide did experience a small amount of weight loss. Like Byetta, Amylin’s (NASDAQ:AMLN) GLP-1, the most common adverse event associated with Liraglutide was nausea. As encouraging as these results are the issue for Novo is timing. With Liraglutide expected to be submitted to the Food and Drug Administration (FDA), in mid-2008 if approved the drug would not hit the market until 2009, about one year before the long-acting once a week version of Byetta is expected to be on the market. Given the option of waiting for Byetta LAR or using once-daily Liraglutide Diabetic Investor suspects the majority of physicians will wait for LAR. Liraglutide appears to be fine drug but serves as another example of Novo’s inability to bring new drugs to market in a timely fashion. With Byetta already well established in the market and LAR around the corner it’s difficult to find a market for Liraglutide. Based on what we know so far both Byetta and Liraglutide are effective at lowering A1c with Byetta doing a better job of promoting weight loss. Unless something else comes from Novo there are no compelling reasons for physicians to switch patients from Byetta to Liraglutide. David Kliff Publisher Diabetic Investor www.diabeticinvestor.com www.davesrunfordiabetes.blogspot.com 847-634-4777 800-783-3712 847-634-4646 fax 224-715-3761 mobile
