NICE approves Novo's diabetes therapy, with caveats
As an initiative to curb the rise of diabetes in the U.K., the National Institute for Health and Clinical Excellence has approved the usage of liraglutide (Victoza, Novo Nordisk) for treatment of type 2 diabetes as a triple therapy regimen, however the agency said data do not yet provide clear evidence to recommend the drug as a stand-alone treatment for type 2 diabetes
In the recent draft guidance, NICE recommends the drug for patients who are unable to control diabetes with their current treatments such as metformin and a sulfonylurea or metaformin and a thiazolidinedione. The recommendations suggest that patients be given liraglutide in addition to their current treatments.
The drug has been indicated for use in patients who are overweight with a body mass index (BMI) of 35 or higher. While the drug is recommended for obese patients, those with a BMI lower than 35 can also benefit from the drug. According to NICE, liraglutide can help achieve weight loss goals and treat other conditions related to obesity in patients.
Although approved, the committee found that “there were disparities in the data provided by the manufacturer, particularly regarding the economic analyses of liraglutide in dual-therapy regimens for this type of diabetes.”
The drug is not advised for use in dual therapy or in 1.8 mg daily doses. However, 1.2 mg daily doses is a recommended therapy for type 2 diabetes and obese patients.
Last month, the FDA consented liraglutide for use in patients with type 2 diabetes, but required Princeton, NJ.-based Novo to conduct further studies to examine its safety and efficacy.
“The next step for the manufacturer is to consider the committee’s comments and respond to its concerns,” NICE wrote.
In the recent draft guidance, NICE recommends the drug for patients who are unable to control diabetes with their current treatments such as metformin and a sulfonylurea or metaformin and a thiazolidinedione. The recommendations suggest that patients be given liraglutide in addition to their current treatments.
The drug has been indicated for use in patients who are overweight with a body mass index (BMI) of 35 or higher. While the drug is recommended for obese patients, those with a BMI lower than 35 can also benefit from the drug. According to NICE, liraglutide can help achieve weight loss goals and treat other conditions related to obesity in patients.
Although approved, the committee found that “there were disparities in the data provided by the manufacturer, particularly regarding the economic analyses of liraglutide in dual-therapy regimens for this type of diabetes.”
The drug is not advised for use in dual therapy or in 1.8 mg daily doses. However, 1.2 mg daily doses is a recommended therapy for type 2 diabetes and obese patients.
Last month, the FDA consented liraglutide for use in patients with type 2 diabetes, but required Princeton, NJ.-based Novo to conduct further studies to examine its safety and efficacy.
“The next step for the manufacturer is to consider the committee’s comments and respond to its concerns,” NICE wrote.