Product
Victoza
Approval Date
January 25, 2010
Release Date
February 16, 2010
Company
Novo Nordisk
Class
Anti-diabetic (glucagon-like peptide-1 (GLP-1) analog)
Indication
As an adjunct to diet and exercise to improve blood sugar control in adults with type 2 diabetes.
Active Ingredient
Liraglutide [rDNA origin] 6mg/mL; soln for SC inj.
Agency Roster
Cline Davis Mann (professional AOR)
Grey Healthcare Group (DTP)
Digitas Health (digital, non-search online media)
Marketing Strategy/Execution
Novo Nordisk is supporting the launch of Victoza with an aggressive marketing campaign that stresses its ability to do more than reduce blood-sugar levels. Victoza (liraglutide), a glucagon-like peptide-1 (GLP-1) analog for the treatment of type 2 diabetes, works in a similar fashion to Eli Lilly’s twice-daily Byetta but requires one less injection per day. Consumer and professional elements, such as Victoza.com and VictozaPro.com along with journal ads in Monthly Prescribing Reference and JAAPA, of course highlight A1c-lowering potential and once-daily administration, but an added clinical benefit also shows up prominently in communications: weight loss. Although Victoza isn’t indicated for managing obesity, one study showed that it provided greater weight loss than Merck’s Januvia, which is a benefit for patients with type 2 diabetes struggling to maintain healthy weight. Direct-to-patient programs and advertising are set to echo the theme of doing more than lowering blood glucose. For the time being, physicians expect Victoza to take significant share from Byetta, at least until the arrival of a once-weekly GLP-1 by the name of Bydureon, which is being developed by Eli Lilly.
Physician Outlook
According to GfK Healthcare’s 2010 Type 2 Diabetes Physician Study, conducted just after Victoza’s approval in January, endos are more likely than PCPs to be aware of Victoza and more likely to say they will prescribe it, though to a relatively small proportion of patients. Physicians are more likely to use Victoza to replace Byetta rather than oral anti-diabetes medications. It remains to be seen whether the concerns about the safety of the GLP-1 class and the tendency to use the class for especially obese patients will inhibit broader prescribing of Victoza.
– David Jacobson, SVP, diabetes practice leader, Roper Diabetes Group, GfK Healthcare
Also in the Pipeline (courtesy of Adis R&D Insight)
Drug: AVE-0010
Manufacturer: Zealand Pharma
Indication: Type 2 diabetes mellitus
Active ingredient: Lixisenatide
Phase: III
Drug: BMS 512148
Manufacturer: Bristol-Myers Squibb
Indication: Type 2 diabetes mellitus
Active ingredient: Dapagliflozin
Phase: III
Drug: NN1250
Manufacturer: Novo Nordisk
Indication: Type 2 diabetes mellitus
Active ingredient: Insulin degludec
Phase: III
Drug: MK 0431D
Manufacturer: Merck
Indication: Type 2 diabetes mellitus
Active ingredient: Sitagliptin/simvastatin
Phase: III
Drug: D-tagatose
Manufacturer: Spherix
Indication: Type 2 diabetes mellitus
Active ingredient: Tagatose
Phase: Preregistration
Drug: Bydureon
Manufacturer: Eli Lilly
Indication: Type 2 diabetes mellitus
Active ingredient: Exenatide long-acting release
Phase: Preregistration
Drug: JNJ 28431754
Manufacturer: Tanabe Seiyaku
Indication: Type 2 diabetes mellitus
Active ingredient: Canagliflozin
Phase: III
Drug: Insulin aspart/NN1250
Manufacturer: Novo Nordisk
Indication: Type 2 diabetes mellitus
Active ingredient: Insulin degludec/insulin aspart
Phase: III
Drug: BIM 51077
Manufacturer: Ipsen
Indication: Type 2 diabetes mellitus
Active ingredient: Taspoglutide
Phase: III
Drug: Technosphere Insulin
Manufacturer: MannKind
Indication: Type 2 diabetes mellitus
Active ingredient: Insulin inhalation
Phase: Preregistration
Drug: Dutogliptin tartrate
Manufacturer: Phenomix
Indication: Type 2 diabetes mellitus
Active ingredient: Dutogliptin
Phase: III
Drug: Nesina
Manufacturer: Takeda San Diego
Indication: Type 2 diabetes mellitus
Active ingredient: Alogliptin
Phase: Preregistration
Drug: Galvus
Manufacturer: Novartis
Indication: Type 2 diabetes mellitus
Active ingredient: Vildagliptin
Phase: III
Drug: BMS-512418/metformin
Manufacturer: Bristol-Myers Squibb
Indication: Type 2 diabetes mellitus
Active ingredient: Dapagliflozin/metformin
Phase: III
Drug: Metformin/saxagliptin
Manufacturer: Bristol-Myers Squibb
Indication: Type 2 diabetes mellitus
Active ingredient: Saxagliptin/metformin
Phase: Preregistration
Drug: R 1439
Manufacturer: Roche
Indication: Type 2 diabetes mellitus
Active ingredient: Aleglitazar
Phase: III
Drug: VIAject
Manufacturer: Biodel
Indication: Type 2 diabetes mellitus
Active ingredient: Insulin injectible
Phase: Preregistration
Drug: BI 1356
Manufacturer: Boehringer Ingelheim
Indication: Type 2 diabetes mellitus
Active ingredient: Linagliptin
Phase: III
Drug: S 21403
Manufacturer: Kissei Pharmaceutical
Indication: Type 2 diabetes mellitus
Active ingredient: Mitiglinide
Phase: III
Drug: GLP-1 Fc
Manufacturer: Eli Lilly
Indication: Type 2 diabetes mellitus
Active ingredient: LY 2189265
Phase: III
Drug: MK-0431C
Manufacturer: Merck
Indication: Type 2 diabetes mellitus
Active ingredient: Sitagliptin/pioglitazone
Phase: III
Drug: Alogliptin/Actos
Manufacturer: Takeda
Indication: Type 2 diabetes mellitus
Active ingredient: Alogliptin/pioglitazone
Phase: Preregistration
Drug: Icandra
Manufacturer: Novartis
Indication: Type 2 diabetes mellitus
Active ingredient: Vildagliptin/metformin
Phase: Preregistration
Drug: Metgluna
Manufacturer: Kissei Pharmaceutical
Indication: Type 2 diabetes mellitus
Active ingredient: Mitiglinide/metformin
Phase: III
Source: Wolters Kluwer Pharma Solutions
Recent MM&M Coverage
Novo reps to spotlight weight loss for Victoza launch
Company News: Novo Nordisk, MedPage Today and American Academy of Family Physicians
Pharmacology
Liraglutide is an analogue of human GLP-1 that acts as an agonist at GLP-1 receptors. Its properties differ from those of the native protein in that it has a longer half-life, enabling it to be dosed once-daily. Its actions include increasing intracellular cAMP, resulting in insulin release in the presence of increased glucose concentrations. This insulin secretion subsides as glucose levels normalize. Liraglutide also decreases glucagon secretion and delays gastric emptying, both of which contribute to its therapeutic effect. It has been shown to reduce fasting, premeal, and postprandial glucose throughout the day.
Clinical Trials
Five double-blind, randomized, controlled clinical trials were conducted to assess the efficacy of liraglutide in the management of type 2 diabetes. In a 52-week monotherapy trial, 746 patients were randomized to liraglutide 1.2mg or 1.8mg or glimepiride 8mg. Treatment with liraglutide resulted in significant reductions in HbA1c compared to glimepiride.
A 26-week study involving 1091 patients compared three doses of liraglutide (0.6mg, 1.2mg, and 1.8mg), glimepiride 4mg, and placebo as add-on therapy to metformin. The addition of liraglutide 1.2mg and 1.8mg resulted in a significant mean HbA1c reduction compared to placebo and a similar mean HbA1c reduction compared to glimepiride.
In a 26-week study in 1041 patients that compared three doses of liraglutide (0.6mg, 1.2mg, and 1.8mg), rosiglitazone 4mg, and placebo as add-on therapy to glimepiride, treatment with liraglutide 1.2mg and 1.8mg resulted in a significant reduction in mean HbA1c , compared to placebo as add-on to glimepiride.
A 26-week study in 581 patients compared liraglutide 1.8mg, placebo, and insulin glargine as add-on therapy to metformin and glimepiride. Treatment with liraglutide, as add-on to metformin and glimepiride, resulted in significant mean reduction in HbA1c compared to placebo add-on to metformin and glimepiride.
Lastly, a 26-week trial compared liraglutide 1.2mg, liraglutide1.8mg, and placebo as add-on therapy to metformin 2g and rosiglitazone 8mg. Treatment with liraglutide as add-on to metformin plus rosiglitazone resulted in a significant reduction in mean HbA1c , compared to placebo.
Adverse Reactions
Headache, GI upset, antibody formation, immunogenicity reactions (eg, urticaria), constipation, anorexia; rare: pancreatitis (discontinue if occurs), papillary thyroid carcinoma.
Give by SC inj in abdomen, thigh, or upper arm once daily. Initially 0.6mg/day for 1 week, then 1.2mg/day; may increase to 1.8mg/day.
Children
<18yrs: not recommended.
Precautions
Not for treating type 1 diabetes or ketoacidosis. Not recommended for first-line treatment in patients inadequately controlled on diet and exercise. Pancreatitis; monitor for signs/symptoms. Renal or hepatic dysfunction. Gastroparesis. Inform patients of thyroid cancer risk and symptoms. Pregnancy (Cat.C). Nursing mothers: not recommended.
Interactions
Concomitant insulin (insufficient data). Hypoglycemia with insulin secretagogues (consider reducing their doses). May affect absorption of other drugs (delayed gastric emptying). Monitor digoxin.
