First generic GLP-1 receptor agonist launched
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Key takeaways:
- The first generic GLP-1 receptor agonist in the U.S. has been launched.
- Liraglutide 1.8 mg is indicated for glycemic control in patients with type 2 diabetes and reduction of heart events in certain patients.
Teva Pharmaceuticals announced it has launched the first generic version of a GLP-1 receptor agonist in the United States, liraglutide 1.8 mg.
GLP-1 receptor agonists have demonstrated benefits in diabetes, cardiovascular and kidney outcomes as well as weight loss. The generic version of liraglutide 1.8 mg is indicated to improve glycemic control in patients aged 10 years or older with type 2 diabetes and to reduce risk for CV events in adults with type 2 diabetes and established heart disease, according to a press release issued by the company.
The brand-name version of liraglutide 1.8 mg (Victoza, Novo Nordisk) had annual sales of $1.656 billion as of April, according to the release.
“By launching an authorized generic for Victoza (liraglutide injection 1.8 mg), we are providing patients with type 2 diabetes another option for this important treatment,” Ernie Richardsen, senior vice president and head of U.S. commercial generics at Teva, said in the release. “In addition to strengthening Teva’s diverse complex generics portfolio, we are providing the first generic GLP-1 product to the U.S. marketplace, demonstrating once again our ability to sustain a generics powerhouse.”
Liraglutide 1.8 mg is not indicated for patients with type 1 diabetes and has not been tested in children younger than 10 years. The most common adverse events of liraglutide injection may include nausea, diarrhea, vomiting, decreased appetite, indigestion and constipation. The most serious adverse events of liraglutide may include pancreatitis, hypoglycemia and thyroid tumors.
Perspective
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Susan Cornell, PharmD, CDE, FAPhA, FAADE
It has been over 14 years since the first long-acting, GLP-1 receptor agonist became FDA approved. The GLP-1 receptor agonist class of medications initially approved for the treatment of diabetes and later for obesity had a slow start in acceptance and prescribing. However, that trend has had a dramatic change in the past few years, with the GLP-1s now being the most sought out medication class to treat obesity and diabetes.
With the data obtained from the cardiovascular outcome trials, it is now known that some of the agents in the GLP-1 receptor agonist class have CV and kidney benefits, in addition to glucose lowering and weight loss. Ongoing clinical trials indicate even more benefits with GLP-1 receptor agonists will be identified in the future.
Though, despite all the benefits of the GLP-1s, patients often struggle with access to these superpowered medications; cost being one of the major concerns even for those with prescription drug coverage. It is exciting to have a more affordable generic option. This will hopefully provide access to this medication for people who truly need it.
It should be noted that liraglutide is a once-daily injectable GLP-1 receptor agonist, whereas many of the newer GLP-1 products are dosed once weekly. It will be interesting to see adherence outcomes. In GLP-1 receptor agonist-naive patients starting the generic liraglutide, once daily, adherence may not be a concern. However, for people who may switch from a once-weekly to a once-daily dosing regimen, adherence will need to be monitored. These are truly exciting times in the world of diabetes care and management.
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