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Type 2 Diabetes Weekly Injectable Drug Approved
- Updated: September 22, 2014
A new weekly injectable drug called Trulicity for people with Type 2 Diabetes has been approved by the United States Food and Drug Administration (FDA). This particular medication is in a class of once-a-week injectable drugs developed to manage blood sugar levels in adults living with this disease.
As stated by Dr. Mary Parks, deputy director of the Office of Drug Evaluation II with the FDA, Trulicity is not only a new treatment option for people with Type 2 Diabetes but also something that can be used as a standalone treatment or in conjunction with other treatment regimens in an effort to control blood sugar levels.
Currently, there are approximately 26 million people in the United States alone who have Type 2 Diabetes, being the most common among the different types of diabetes, which accounts for more than 90% of all cases. With Type 2 Diabetes, blood sugar levels skyrocket. As a result, an individual can face very serious complications to include kidney damage, liver damage, visual problems, and heart disease.
The newly approved drug, Trulicity, which is generically called “dulaglutide”, is a glucagon-like peptide-1 (GLP-1) receptor agonist drug, which reduces high blood sugar levels. Prior to being approved, six clinical trials were evaluated by the FDA. These studies consisted of 3,500 participants, all with Type 2 Diabetes.
As part ofthese studies, Trulicity was studied as a standalone drug and in combination with other treatments and medications used for this disease such as mealtime insulin injections, Metfomin, and others. Researchers found that participants who injected Trulicity weekly had marked improvement in long-term blood sugar levels.
Although Trulicity reduces high levels of blood sugar, there are some side effects to include abdominal pain, vomiting, diarrhea, nausea, and decreased appetite. According to the FDA, the drug will come with a warning label indicating that in rodents, some GLP-1 receptor agonists have been linked to thyroid tumors.
The FDA also advised that Trulicity should never be prescribed to patients who personally have or with a family history of medullary thyroid carcinoma, which is a specific type of thyroid cancer. In addition, Trulicity is not intended for patients with multiple endocrine neoplasia syndrome type 2 since these individuals have tumors in multiple glands within the body, making them at greater risk for developing medullary thyroid carcinoma.
Manufactured by Eli Lilly and Company, Trulicity was developed only for adults with Type 2 Diabetes, not Type 1. It should also not be prescribed to people with intestinal or serious stomach problems. The FDA also stated that the newly approved Trulicity should not be the first drug used to treat Type 2 Diabetes.
Eli Lilly and Company will be required by the FDA to conduct several post-marketing studies that will focus on evaluating cardiovascular issues specific to people with a higher risk of heart problems.