GlaxoSmithKline (GSK), the renowned research-based pharmaceutical and healthcare firm, has finally received the green signal in the US for marketing its once-weekly diabetes drug Tanzeum which the company expects to launch in third quarter 2014.
On April 15, FDA approved GSK’s new drug Tanzeum. The drug is a subcutaneous injection that is used to treat Type-2 diabetes. It can be injected once a week when paired with a strict diet regiment and exercise in order to reduce blood glucose levels.
There are several factors that can contribute to the onset of Type-2 diabetes. Obesity, lack of exercise, high blood pressure, genetics and side effects of some other drugs are the most well known causes. Diabetes increases blood sugar level, which may lead to serious health complications such as blindness and cardiac problems including nerve and kidney damage. Approximately 24 million people have been diagnosed with this disease with more than 90 percent of diabetic patients suffering from Type 2 diabetes.
Director of the Office of Drug Evaluation II in the FDA’s Center for Drug Evaluation and Research, Curtis Rosebraugh, M.D., M.P.H., reportedly said,
"Tanzeum is a new treatment option for the millions of Americans living with type 2 diabetes. It can be used alone or added to existing treatment regimens to control blood sugar levels in the overall management of diabetes.”
About The Drug
Tanzeum (Albiglutide) is a glucagon-like peptide-1 receptor agonist (GLP-1), an incretion hormone that helps to reduce blood glucose levels in patients. FDA has approved the drug on the basis of the results of GSK’s comprehensive phase III Harmony Program where the drug’s safety and effectiveness were assessed in eight clinical trials involving over 2000 diabetic patients with Type 2 diabetes. The harmony studies evaluated that the administration of Tanzeum has improved patients’ hemoglobin A1c (a measure of blood sugar control).
Restriction of application in some cases
Tanzeum should not be used as first-line therapy for the patients whose disease adequately cannot be controlled with diet and exercise. The effect of the drug has been studied separately, as well as, in combination with other Type 2 diabetes therapy, including metmorphin, glimepiride, insulin and pioglitazone. This drug is strictly restricted to treat people who are suffering from Type 1 diabetes with increased ketones in their blood or urine (diabetic Ketoacidosis).
Adverse Effects for Some Patients
Tanzeum comes with a boxed warning which state that tumors of the thyroid gland (thyroid C cell tumors) have been observed in rodent studies with some GLP-1 receptor agonists, but it is not known whether Tanzeum causes the tumors in humans. The FDA also claimed that patients with personal or family history of medullary thyroid carcinoma (MTC) or patients with Multiple Endocrine Neoplasia Type 2 (patients having tumors in more than one gland that predisposes one to MTC) should not use the medicine.
The Drug Administration has also insisted on conducting a survey on post marketing studies in children, as well as, cardiovascular outcomes trial along with an MTC case registry of at least last 15 years duration. After several clinical tests common side effects such as diarrhea, nausea and injection site reaction have been observed. Furthermore, Tanzeum should be used cautiously when treating patients with pancreatitis, hypoglycemia or renal impairment. The patients should be kept under supervision as the drug may be fatal to them.
In recent times, diabetes has progressed from being a fairly rare malady to a highly prevalent one. The CDC claims that one of every 3 adults could have diabetes by 2050. It is a permanent fixture, incurable. In such trying circumstances, GlaxoSmithKline provides us a ray of hope. The company has given the assurance to be benefited by using Tanzeum therapy and also committed to improve human life. The drug provides a much needed solution to the diabetes problem and already results are optimistic, so much so that a report by Reuters’ expects the drug to hit $430 million in sales by 2018.