Weighing in on obesity
How Contrave and liraglutide could succeed in obesity
Contrave naltrexone/bupropion will be the first new obesity drug launched in the past two years to have the full weight of a large pharma partner with an established commercial footprint in the cardiometabolic space behind it. The same is true for liraglutide, which is waiting in the wings. This experience could help get skeptical physicians off the sidelines and into the business of treating weight loss with more than just diet and exercise; however, payers will still need evidence that the weight loss translates into real world benefits. Otherwise these new entrants could languish just like the products that came before them.
On Sept. 10, FDA approved Contrave from Orexigen Therapeutics Inc. and Takeda Pharmaceutical Co. Ltd. as an adjunct to diet and exercise to manage weight loss in people with a BMI of at least 30 kg/m2 or in people with a BMI of at least 27 kg/m2 and at least one co-morbidity.
The winding road to Contrave's approval included a complete response letter from FDA and a premarket cardiovascular outcomes trial. Orexigen will have to do a second cardiovascular outcomes trial postmarket, but the company and partner Takeda are now focused on the drug's launch, which is slated for the fall (see "Pandora's CVOT," page 8).
Just one day after Contrave's approval, FDA's Endocrinologic and Metabolic Drugs Advisory Committee voted 14-1 to recommend approval of Novo Nordisk A/S's 3 mg liraglutide to treat obesity. The drug is approved as Victoza at doses of 1.2 mg and 1.8 mg for diabetes, and the panel concluded Novo had not only demonstrated efficacy in obesity, but that the current postmarket experience with Victoza as well as an ongoing cardiovascular outcomes trial was sufficient to address any potential safety concerns raised by the agency. The proposed brand name for 3 mg liraglutide is Saxenda.
If FDA approves Saxenda by its Oct. 20 PDUFA date, the long-acting analog of glucagon-like peptide-1 (GLP-1) would be the fifth obesity drug on the market and the fourth approved by FDA since 2012.
The surge of new obesity drugs has not been matched in the marketplace. Qsymia phentermine/topiramate from Vivus Inc. and Belviq lorcaserin from Arena Pharmaceuticals Inc. and Eisai Co. Ltd. were launched in 2012 and 2013, respectively, but have had lackluster sales.
One barrier to uptake has been hesitancy by primary care physicians to wade