Novo Nordisk’s obesity drug candidate Saxenda®—a new indication and dosage for its already-marketed diabetes drug Victoza®—is on track toward an expected FDA approval following an advisory panel’s favorable recommendation yesterday.
The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee voted 14–1 to recommend approval of Saxenda for chronic weight management in adults with obesity or overweight with comorbidities, as an adjunct to diet and exercise. Saxenda is a new 3 mg dosage of Victoza (liraglitude), now marketed for type 2 diabetes at 1.2 and 1.8 mg once-daily, as well as at 0.9 mg in Japan.
“We are pleased with the clear recommendation from the Advisory Committee,” Mads Krogsgaard Thomsen, evp and CSO of Novo Nordisk, said in a statement. “Obesity is a serious public health issue in the US and we are committed to making Saxenda® a new treatment option for adults with obesity.”
In recommending approval of Saxenda, the advisory committee cited data from clinical trials of Saxenda, including the Phase III SCALE™ clinical trial program, which saw enrollment by nearly 6,000 people with obesity or who were overweight with comorbidities.
In four Phase III trials, the lowest percentage of Saxenda-treated patients who reported weight loss of 5% or more was the 46.6% recorded in Trial 3970 (32 weeks of treatment in 359 obese patients with obstructive sleep apnea randomized to Saxenda or placebo). The highest was the 63.5% recorded in Trial 1839 (56 weeks plus 12 weeks re-randomized treatment period in 3,731 overweight or obese patients with or without prediabetes).
The highest percentage in the clinical program was the 78.1% recorded in the Phase II Trial 1807 (20 weeks plus 84-week extension, with interim analysis in 52 weeks, in 564 obese patients assessed for three dosages of Saxenda and randomized to that drug as well as to placebo and orlistat).
Saxenda would be indicated for chronic weight management in individuals with a BMI 30 kg/m2 or greater, or 27 kg/m2 or greater in the presence of at least one weight-related comorbidity.
That is the same indication for which the FDA on Wednesday approved Contrave® (naltrexone HCI and bupropion HCI) extended-release tablets. However, the approval came with a boxed warning agreed upon by Contrave’s developers Takeda Pharmaceuticals USA and Orexigen Therapeutics, while the FDA required them to complete numerous additional postmarketing studies.
The FDA has set October 20 as its Prescription Drug User Fee Act (PDUFA) date for completion of its review of Saxenda’s NDA, submitted to the agency on December 20, 2013.