New findings on Januvia bode well for approval
Dipeptidyl peptidase-4 (DPP-4) inhibitor sitagliptin (Januvia, Merck), currently under review by the FDA, can cause a 2.1 percentage point drop in A1c levels in patients receiving the drug in conjunction with metformin, according to study results released at the 42nd Annual Meeting of the European Association for the Study of Diabetes this week.
Dipeptidyl peptidase-4 (DPP-4) inhibitor sitagliptin (Januvia, Merck), currently under review by the FDA, can cause a 2.1 percentage point drop in A1c levels in patients receiving the drug in conjunction with metformin, according to study results released at the 42nd Annual Meeting of the European Association for the Study of Diabetes this week. Patients received either combination treatment with metformin (1,000 mg) and sitagliptin (50 mg twice daily) or just metformin alone. Results showed that 66% of patients in the combination group were able to achieve the target goal of an A1c level of less than 7%, compared with only 38% in the metformin group. A final FDA decision for marketing of Januvia is expected in October.
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FDA’s Recent Exemptions: What Do They Mean as We Finalize DSCSA Implementation?
October 31st 2024Kala Shankle, Vice President of Regulatory Affairs with the Healthcare Distribution Alliance, and Ilisa Bernstein, President of Bernstein Rx Solutions, LLC, discussed recent developments regarding the Drug Supply Chain Security Act.
