Sharing our perspective

Sharing perspectives leads to greater understanding and fuels innovation. The ​Optum Insights ​blog is where we share our perspective and challenge preconceptions to clear a new path forward.


New drug therapy approvals in 2017

by
Optum Workers' Comp
| Feb 01, 2018

The U.S. Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) has published their annual report, Advancing Health through Innovation: New Drug Approvals and Other Drug Therapy Advances of 2017.  This report not only summarizes the approval of 46 new medications in 2017, it also provides information on the CDER’s role in supporting the FDA’s efforts to endorse innovation, efficiently execute the review and approval of new medications while maintaining patient safety, and improve various treatments for patients. According to this report, the CDER used at least one expedited development and review method for 61 percent (28) of the 46 new medication approvals and approved 78 percent (36 of 46) of the new medications in the U.S. before any other country.

This report highlights the approval of new medication therapies to treat patients in need and those suffering from rare diseases, as well as a wide range of medical conditions, new biosimilars and new dosage formulations and uses for medications already on the market, extending benefits to new populations.  

While many of these medications are not often used to treat injuries related to workers’ compensation claims, we have highlighted some of these new product launches in our blog and Clinical Info Newsletters over the past year, including the approval of Symproic®, Sublocade™, RoxyBond™,  Vantrela™ ER, Arymo® ER, and Vosevi®.

To access the CDER’s 2017 report in its entirety, please click here.

If you have any questions regarding these medications, please contact your account manager, clinical liaison or our Clinical Services team at 1-877-275-7674 ext. 8612.

 

Sources
1. U.S. Food and Drug Administration. Center for Drug Evaluation and Research. Advancing Health through Innovation. 2017 New Drug Therapy Approvals. January 1, 2018. Available at https://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ReportsBudgets/UCM591976.pdf

2. U.S. Food and Drug Administration. FDA Voice. Many “Firsts” for CDER’s 2017 Drug Approvals Reflect Innovation and Enhanced Patient Care. January 10, 2018, Available at https://blogs.fda.gov/fdavoice/index.php/2018/01/many-firsts-for-cders-2017-drug-approvals-reflect-innovation-and-enhanced-patient-care/