Sunday, January 29, 2012

USFDA approves Bydureon -The first every Once weekly diabetes drug

After a long delay the USFDA gave a nod to Bydureon - A once weekly GLP-1 injection. The drug  was approved by EU regulators last year and is the first once weekly medication to be approved for the treatment of diabetes by the USFDA. Weight loss, lower hypoglycemia rates, robust efficacy together with the compliance benefit, is likely to make it a preferred treatment option for diabetes patients.
Bydureon has been approved as adjunct to diet and exercise to improve glycemic control in type 2 diabetes patients in  multiple clinical settings.
The contraindications include:
  • Not in type 1 diabetes patients
  • Not as first line therapy in patients who do not adequately respond to diet and exercise
  • Bydureon has not been studied in combination with insulin, hence it should not be concomittantly administered with insulin

The full label of the drug can be accessed at http://www.accessdata.fda.gov/drugsatfda_docs/label/2012/022200s000lbl.pdf