Matthew Mintz, MD, Internal Medicine, 03:43PM Jan 28, 2012
Let the games begin! After two prior failures, the FDA just announced the approval of Bydureon, which is exenatide extended-release. You may know exenatide as Byetta, which is the un-extended release form delivered in a twice daily injection. The advantage of Bydureon is that it can be delivered once a week.
Both exenatide and liraglutide (Victoza) are one of the new classes of diabetes medications know called glucagon-like peptide-1 (GLP-1) receptor agonist. Byetta was the first on the market, and became popular because, in addition to glycemic control, the GLP-1 analogues don't cause hypoglycemia and can help with weight loss. However, in recent days Victoza has become the more popular agent in the US because it is administered only once a day (and seems to have fewer side effects and better weight loss).
Now with a 3rd product on the market, it will be interesting to see which agent will be physician's GLP-1 of choice. Here are a few factors that may make a difference.
The convenience factor: The main issue will boil down to how much value patients value taking one injection a day compared to one injection per week. Administration (see below) of Bydureon is not exactly easy, so it will be interesting to see how convenience compares to ease of use in physician's minds.
The administration factor: If Bydureon came in an easy to use pen, there would probably be no contest. However, Bydureon is a powder that must be first mixed and then immediately injected subcutaneously. Not impossible, but not as easy as a pen. Here's exactly what it says in the recently approved package insert:
The cost factor: Sometimes, when a patient is choosing between two branded products in the same class it boils down to how much it will cost them out of pocket. Victoza currently offers $25 off co-pays for 2 years. This is not bad for a prescription drug discount. However, if Amylin gets into the coupon war, and guarantees patients a very low co-pay for Bydureon, they make gain a few more customers.
The weight factor: One of the main advantages of the GLP-1 agonists is that weight loss is a major "side effect." Novo nordisk, makers of Victoza, is actually currently studying higher doses of liraglutide in attempts to get a weight loss indication, even for non-diabetics. Extended release exenatide does not seem to confer any weight loss advantage over Byetta, with patients losing about 2kg in about 24 weeks. Weight loss in Victoza studies is closer to 3kg. This difference may be enough to convince patients wanting to lose weight to go with once daily Victoza over once weekly Bydureon.
The head to head factor: Usually, when there are two or more drug companies competing with a class, the company's sales force touts their product's benefits and the competition's weaknesses. This is all meaningless, of course, unless you have a true head to head comparison, which is generally rare. However, we actually do have a comparison. Lilly/Amylin failed to prove non-inferiority of Bydureon to Victoza in it's head to head comparison in A1c reductions (1.3 vs. 1.5). Weight loss was also greater with Victoza. The only bright spot for Bydureon was that it caused less nausea (9% Bydureon vs. 20% Victoza).
The Amylin factor- For those of you see pharmaceutical reps, you may connect Byetta with Lilly. However, the two companies "divorced" back in November, mostly due to Lilly's partnership with BI to market the DPP4-inhibitor Tradjenta (which many would say is a direct competitor with GLP-1 analogues such as Byetta and Bydureon. Amylin doesn't have nearly the sales force that Lilly or Novo Nordisk has, so it will be interesting to see how they compete when they are sufficiently out-manned.
The Paula Deen factor- Possibly in anticipation of Bydureon's approval, Novo Nordisk recently announced its partnership with celebrity chef Paula Deen. Ms. Deen is known for her less than healthy cooking, and announced that she was diagnosed with type 2 diabetes 3 years ago. On the one hand, having a celebrity spokesperson may increase patients awareness of Victoza and requesting prescriptions from their doctors. On the other hand, there was quite a public backlash over Novo's choice of a celebrity spokesperon as well as Ms. Deen's unwillingness to admit that she would change her eating and lifestyle habits. It might be possible that physicians and patients shy away from Victoza due to their discontent with Novo's choice/Ms. Deen's public statements.