Liraglutide Given Green Light by FDA Advisory Panel

FAD’s Advisory Panel Approves Liraglutide

In November 2008, Novo Nordisk initiated a PIII clinical trial of liraglutide for the treatment of obesity. After conducting a series of Liraglutide clincal trials and overcoming major and minor set-backs, the drug has finally received a positive assessment from the advisory panel of the FDA with a vote of 14-1 in favor of the drug’s approval as a treatment for obesity. This drug which will be sold under the name Saxenda if approved as a treatment for obesity is currently available in the United Kingdom but is known to diabetics by the name Victoza as it is already licensed in the United Kingdom as a treatment for Type 2 diabetes. 

Diabetes which is one of the leading causes of death and disability in the world is the result of glucose building up in the blood due to the pancreas not producing sufficient insulin which is the hormone that regulates the amount of sugar that builds up in the blood. As Victoza, the drug is intended to lower blood sugar levels when used in combination with exercise, a proper diet and other selected diabetes medicines. Victoza is classified as a glucagon-like peptide-1 (GLP-1) receptor agonists and as such, it helps the pancreas in our body to produce more insulin after eating a meal in order to prevent glucose from building up in the blood. The most common side effects observed resulting from the use of Victoza are:

diarrhoea

headache 

nausea

Difference between Victoza and Saxenda

So what exactly is the difference between Victoza and Saxenda? Why does the FDA need to approve liraglutide again if it has already been approved? Why is a new name necessary? Well, first of all, the main difference between Victoza and Saxenda is that Victoza has been approved as a 1.8mg per day dose for diabetes. It is prescribed off-label and can be purchased at this UK site but only at 1.8 mg per day maximum. Saxenda on the other hand will be for 3.0 mg per day. Although Victoza materials say that the drug may help you to lose weight, it is not indicated as a weight-loss drug and if it were to be sold as a weight loss drug it would go against the FDA’s label. This is the main difference between the two drugs and why a new name was needed. Some may wonder if it is necessary to purchase Saxenda when you can double the dosage of Victoza. Well, this is not advisable and it is definitely not an option. Doubling the Victoza dosage would be exceeding the 3mg dosage of Saxenda. Instead of a 3mg dosage, you will be taking a 3.6mg dosage if you choose to double the Victoza dosage.

Although the advisory panel of the FDA has voted in favor of Saxenda, approval by the FDA is not assured; however, it is expected by October. One of the reasons why the FDA’s approval is not assured as yet is the fact that plenty of concerns are still linked to the drug. The trials have revealed that the use of the drug has resulted in rare cases of pancreatitis and that it can increase the risks of thyroid and breast cancer. However, if this drug is approved as a treatment for obesity, Bloomberg reports that it could bring in $556 million in sales by 2018. Novo Nordisk, however, believes that there is sufficient potential for the drug on the market and that the estimated sales as reported by Bloomberg can be doubled. As stated by Mads Krogsgaard Thomsen, the chief science officer of Novo Nordisk, the potential patient group for Saxenda is very large as it will not be targeting obese people alone but those who are overweight as well and are suffering from complications resulting from them being overweight. The panel members who voted in favor of this drug also believes that if it is approved, the risks of using it could be further explored and will require Novo Nordisk to conduct more studies. 

It is a fact that the incidence of obesity has risen dramatically in recent years. There are only a few drugs that are safe and effective on the market, which can be used against obesity. Saxenda can definitely make a difference and can help people to lose weight and live healthier lives. If you would like to have more information on the clinical trials of liraglutide, you can visit the UK's new drugs database. You can also find more information here about this drug, its uses and what can be expected of it if it is officially approved by the FDA as a treatment for obesity. 

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