The U.S. Food and Drug Administration have approved
Saxenda (liraglutide [rDNA origin] injection) as a treatment option for chronic
weight management in addition to a reduced-calorie diet and physical
activity.
The new drug is a glucagon-like peptide-1
(GLP-1) receptor agonist and should not be used in combination with any other
drug belonging to this class, including Victoza, a treatment for type 2
diabetes as both Saxenda and Victoza contain the same active ingredient (liraglutide)
at different doses (3 mg and 1.8 mg, respectively).
The drug got approval for using in adults
with a body mass index (BMI) ranging from 27 to 30 or greater (overweight to
obesity conditons) who are suffering from any of the weight-related condition
such as hypertension, type 2 diabetes, or high cholesterol.
The new drug is a glucagon-like peptide-1
(GLP-1) receptor agonist and should not be used in combination with any other
drug belonging to this class, including Victoza, a treatment for type 2
diabetes as both Saxenda and Victoza contain the same active ingredient
(liraglutide) at different doses (3 mg and 1.8 mg, respectively).
The safety and effectiveness of Saxenda were
evaluated in three clinical trials that included approximately 4,800 obese and
overweight patients with and without significant weight-related conditions.There was an average weight loss of 4.5 percent
from baseline compared to treatment with a placebo (inactive pill) at one year
in a clinical trial that enrolled non diabetic patient. 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.
In another clinical trial where type 2 diabetic patients were enrolled
,the 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.
Pancreatitis, gallbladder disease, renal
impairment, and suicidal thoughts are the serious side effects reported in
patients treated with Saxenda. The drug should be discontinued in patients who
are experiencing a sustained increase in resting heart rate as it can
raise heart rate .
During clinical trial nausea, diarrhea, constipation, vomiting, low blood sugar
(hypoglycemia), and decreased appetite were observed as most common side
effects of patients treated with Saxenda.
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).The FDA had asked for post-marketing studies for Saxenda to evaluate
dosage, safety and efficacy in pediatric patients,potential risk of mTC and
Breast cancer.
In addition, the cardiovascular safety of
liraglutide is being investigated in an ongoing cardiovascular outcomes trial.
The drug is being manufactured and distribuited by Novo Nordisk.
(Courtesy:US FDA)
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