I usually don't prominently mention the brand names of drugs, but in this case there's a reason why: Saxenda and Victoza are exactly the same thing: a glucagon-like peptide-1 (GLP-1) receptor agonist called liraglutide.
Many folks with diabetes probably have heard of liraglutide under the brand name Victoza: it's the stuff that Paula Deen pitched for her own T2D a while ago. It's been a moderate success for the manufacturer, although newer once-weekly GLP-1 agonists have stolen its thunder (or decreased the likelihood that physicians will prescribe it).
One of the favorable "side effects" of the GLP-1 agonist drugs is the likelihood of weight loss, although the Victoza label doesn't mention weight loss amongst the common side effects. But drug companies never fail to exploit side effects (remember, Rogaine wasn't originally developed as a hair restorative product). And a side effect of weight loss is a lovely one for PWD -- especially for obese T2D folks.
So the manufacturer did a bunch of trials, and persuaded the FDA and its Endocrine Advisory Committee to approve using liraglutide as a weight-loss drug. (The AdCom vote for approval was 14 in favor, 1 opposed, no abstentions; the FDA announced its approval this past week, "as a treatment option for chronic weight management in addition to a reduced-calorie diet and physical activity. The drug is approved for use in adults with a body mass index (BMI) of 30 or greater (obesity) or adults with a BMI of 27 or greater (overweight) who have at least one weight-related condition such as hypertension, type 2 diabetes, or high cholesterol (dyslipidemia)."
Several thoughts to chew upon:
1) The manufacturer christened the version of liraglutide for weight loss with a new name: Saxenda. Other companies have played the same deceptive trick: Wellbutrin (for depression) was renamed Zyban (for smoking cessation).
2) The doses used for weight loss are bigger than those for treating T2D. The recommended dose of Saxenda is 3 mg daily (starting, however, at low doses and escalating weekly, to avoid gastrointestinal distress), whereas the recommended dose for Victoza (the version for diabetes) is only 1.8 mg per day.
3) The label for Saxenda has the curious statement that "Saxenda is not indicated for the treatment of type 2 diabetes." Nor should it be used with other GLP-1 agonists, nor with insulin.
4) The drug caused hypoglycemia in 5% or more of patients in clinical trials.
5) The drug continues to have black-box warnings that "liraglutide causes thyroid C-cell tumors at clinically relevant exposures in both genders of rats and mice. It is unknown whether Saxenda causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans, as the human relevance of liraglutide-induced rodent thyroid C-cell tumors has not been determined [and] Saxenda is contraindicated in patients with a personal or family history of MTC or in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2)." There are some other nasty risks mentioned in the Saxenda label -- including pancreatitis, gallbladder disease, renal impairment that might necessitate dialysis, hypersensitivity, and suicidal behavior and ideation.
6) And inevitably, physicians will use the other GLP-1 agonists for weight loss in non-diabetes patients, now that liraglutide showed the way, and some will jump to the conclusion that they can prescribe one of the once-weekly GLP-1 agonists and get the same weight loss results, especially since the once-weekly Bydureon label mentions weight loss was seen in their trials.
Will liraglutide/Saxenda be a successful product for weight loss? I really can't hazard a guess. It requires daily injections, which will freak out some obesity patients. It has the potential for some pretty nasty side effects (but then, so does obesity). It will inevitably be a frequent cause of hypoglycemia in obese diabetes patients, especially if they and their physicians ignore the label's advice. But it's another choice amongst others that have tried and failed to succeed in a huge market (pun intended).
Published On: December 30, 2014