FDA Approves Another Type 2 Diabetes Drug Application
The U.S. Food and Drug Administration has approved an application to review another type 2 diabetes treatment drug. Onglyza (Saxagliptin) is a once-daily fixed dose, extended release metformin treatment for adults with type 2 diabetes mellitus.
Bristol-Myers Squibb Company and AstraZeneca submitted the application with the FDA last December. The New Drug Application (NDA) is based on research from a phase 3 clinical trial that included a change in diet and exercise among the participants, which is required during the Onglyza treatment.
Researchers state the drug should not be used for type 1 diabetes mellitus or diabetic ketoacidosis and Onglyza has not been studied in combination with insulin. Important safety information on the drug further states that hypoglycemia is a risk when taken with other medications.
Pregnant and nursing women are also cautioned because further studies on pregnancy risks or whether the drug can be secreted through breast milk haven't been conducted. Pediatric patients have also been warned about Onglyza's safety and effectiveness.
The collaboration of the biotechnology companies happened in January 2007, when they joined to research, develop and commercialize select investigational drugs for type 2 diabetes. “The Bristol-Myers Squibb/AstraZeneca Diabetes collaboration is dedicated to global patient care, improving patient outcomes and creating a new vision for the treatment of type 2 diabetes.” (Press Release Statement)