FDA approves a powerful new weight loss medication Saxenda!
On December, 23rd, 2014, the U.S. Food and Drug Administration approved a powerful new weight loss drug called Saxenda (liraglutide [rDNA origin] subcutaneous injection) as a treatment option for chronic weight management in addition to a reduced-calorie diet and physical activity, a 2nd such drug to be approved for weight loss in 2014 after approving Orexigen's Contrave(Bupropion and Naltrexone) just a few months ago.
Saxenda, with the same active ingredient as the popular diabetes medication, Victoza, is approved for use in adults with a body mass index (BMI) of 30 or greater (obesity) or adults with a BMI of 27 or greater (overweight) who have at least one weight-related condition such as hypertension, type 2 diabetes, or high cholesterol (dyslipidemia).
What is body mass index?
Popularly called BMI, body mass index measures a person's body fat based on an individual’s weight and height, is used to define the obesity and overweight categories. According to the latest data from the CDC (Centers for Disease Control and Prevention), more than one-third of adults in the United States are obese.
FDA statement while approving Saxenda
At the press briefing before announcing the approval of Saxenda, James Smith, M.D., M.S., (acting deputy director of the Division of Metabolism and Endocrinology Products in FDA’s Center for Drug Evaluation and Research) said "Obesity is a public health concern and threatens the overall well-being of patients. He added Saxenda, used responsibly in combination with a healthy lifestyle that includes a reduced-calorie diet and exercise, provides an additional treatment option for chronic weight management for people who are obese or are overweight and have at least one weight-related comorbid condition.
What is Saxenda?
Saxenda(liraglutide) is a new class of medications called incretins and is a glucagon-like peptide-1 (GLP-1) receptor agonist. A lower dose of exactly the same medication has been on the market for many years as Victoza for the treatment for type 2 diabetes. In other words, Saxenda and Victoza contain the same active ingredient (liraglutide) at different doses (3 mg and 1.8 mg, respectively).
However, Saxenda is not indicated for the treatment of type 2 diabetes, as the safety and efficacy of Saxenda for the treatment of diabetes has not been established and vice versa as data on diabetes control was not presented to the FDA for Saxenda(that is how the FDA works, show them the data).
However, Saxenda is not indicated for the treatment of type 2 diabetes, as the safety and efficacy of Saxenda for the treatment of diabetes has not been established and vice versa as data on diabetes control was not presented to the FDA for Saxenda(that is how the FDA works, show them the data).
Clinical trials evaluating the use and safety of Saxenda
In a trial with about 4,800 obese and overweight patients with and without significant weight-related conditions, that received Saxenda along with counseling regarding lifestyle modifications that consisted of a reduced-calorie diet and regular physical activity, non - diabetic patients had an average weight loss of 4.5 percent from baseline compared to treatment with a placebo (inactive pill) at one year. In this trial, 62 percent of patients treated with Saxenda lost at least 5 percent of their body weight compared with 34 percent of patients treated with placebo.
Results from another clinical trial that enrolled patients with type 2 diabetes showed that patients had an average weight loss of 3.7 percent from baseline compared to treatment with placebo at one year. In this trial, 49 percent of patients treated with Saxenda lost at least 5 percent of their body weight compared with 16 percent of patients treated with placebo.
Results from another clinical trial that enrolled patients with type 2 diabetes showed that patients had an average weight loss of 3.7 percent from baseline compared to treatment with placebo at one year. In this trial, 49 percent of patients treated with Saxenda lost at least 5 percent of their body weight compared with 16 percent of patients treated with placebo.
12 week evaluation
Patients using Saxenda should be evaluated after 16 weeks to determine if the treatment is effective. If a patient has not lost at least 4 percent of baseline body weight, Saxenda should be discontinued, as it is unlikely that the patient will achieve and sustain clinically meaningful weight loss with continued treatment.
Warnings
Saxenda has a boxed warning stating that tumors of the thyroid gland (thyroid C-cell tumors) have been observed in rodent studies with Saxenda but that it is unknown whether Saxenda causes thyroid C-cell tumors, including a type of thyroid cancer called medullary thyroid carcinoma (MTC), in humans. Saxenda should not be used in patients with a personal or family history of MTC or in patients with multiple endocrine neoplasia syndrome type 2 (a disease in which patients have tumors in more than one gland in their body, which predisposes them to MTC).
Side effects
Serious side effects reported in patients treated with Saxenda include pancreatitis, gallbladder disease, renal impairment, and suicidal thoughts. Saxenda can also raise heart rate and should be discontinued in patients who experience a sustained increase in resting heart rate.
The most common side effects observed in patients treated with Saxenda were nausea, diarrhea, constipation, vomiting, low blood sugar (hypoglycemia), and decreased appetite.
The FDA is requiring the following post-marketing studies for Saxenda:
- clinical trials to evaluate dosing, safety, and efficacy in pediatric patients;
- a study to assess potential effects on growth, sexual maturation, and central nervous system development and function in immature rats;
- an MTC case registry of at least 15 years duration to identify any increase in MTC incidence related to Saxenda; and
- an evaluation of the potential risk of breast cancer with Saxenda in ongoing clinical trials.
In addition, the cardiovascular safety of liraglutide is being investigated in an ongoing cardiovascular outcomes trial.
The FDA approved Saxenda with a Risk Evaluation and Mitigation Strategy (REMS), which consists of a communication plan to inform health care professionals about the serious risks associated with Saxenda.
Saxenda is manufactured by Novo Nordisk A/S, Bagsvaerd, Denmark and is distributed by Novo Nordisk, Inc. Plainsboro, New Jersey.
Locations for physicians familiar with Saxenda
W8MD medical weight loss centers is one of the first weight loss centers to start offering Saxenda to eligible patients in addition to diet and exercise.
W8MD's locations for doctors that can prescribe Saxenda
Poly-Tech Sleep, W8MD Weight Loss & MedSpa – King of Prussia, PA
W8MD Weight Loss, Sleep & Medical Spa Cherry Hill, NJ
Related links
Diet pills blog
Frequently asked questions
- What is the most effective drug for weight loss?
- How does Saxenda work in the body?
- How much weight do you lose on Saxenda?
- Where do you inject Saxenda?
- Is Saxenda dangerous?
- What is the best time of day to take Saxenda?
- Can I just stop taking Saxenda?
- How does Saxenda help with weight loss?
- Can I take Saxenda at night?
- Does Saxenda make you pee a lot?
- Which is better for weight loss Saxenda or Victoza?
- Can I drink alcohol on Saxenda?
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