FDA approves Lilly’s once weekly injectable drug Trulicity
The Food and Drug Administration has announced its approval of the injectable GLP-1 agonist drug Trulicity (dulaglutide) which has been developed by pharmaceutical firm, Lilly.
Dulaglutide is a GLP-1 agonist and is therefore in the same class of diabetes medications as Victoza and Byetta. A key advantage Trulicity has, is that it needs to be injected only one per week, compared to rival medications which need to be taken once or more per day.
Trulicity treats type 2 diabetes and has been approved for monotherapy (used on its own) or in combination such as metformin, sulfonylureas, insulin and thiazolidinediones (TZDs).
The new drug performed well in clinical trials, proving itself to be non-inferior to Novo Nordisk’s Victoza. Dulaglutide will, however, come with a health warning which acknowledges that the drug was linked with an increase in thyroid gland tumours when it was tested in rodents. People with a personal or family history of either medullary thyroid carcinoma (MTC) or multiple endocrine neoplasia syndrome type 2 should not take the drug.
Whilst the FDA has recognised the risk of thyroid cancer as being small, it has required Lilly to complete post marketing studies, including maintaining a 15 year registry of cases of MTC.
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