Tresiba and Ryzodeg Approved for Diabetes
September 28, 2015 – The U.S. Food and Drug Administration (FDA) approved two new medications for the treatment of diabetes. Tresiba (insulin degludec) is a once-daily long-acting basal insulin, to improve blood glucose control in adults with type 1 or type 2 diabetes mellitus. Ryzodeg 70/30 is a combination product of insulin degludec and Novolog (insulin aspart), a rapid acting human insulin analog. Tresiba and Ryzodeg are both manufactured by Novo Nordisk.
Tresiba and Ryzodeg will be supplied as 100 Units/mL and 200 Units/mL in FlexTouch pen devices. According to the Centers for Disease Control and Prevention (CDC), approximately 21 million Americans have been diagnosed with diabetes, which is characterized by high blood sugar levels over a prolonged period. Tresiba is expected to be available during the first quarter of 2016. Launch plans for Ryzodeg are not known at this time.
The approval of these two new medications used in the treatment of diabetes is just the beginning of several anticipated changes. Tresiba is anticipated to compete with Lantus (insulin glargine), Toujeo (insulin glargine – Sanofi) both manufactured by Sanofi, and Levemir (insulin detemir) manufactured by Novo Nordisk. It is also anticipated that Biosimilars to Lantus will be available as early as the second half of 2016. Basaglar (insulin glargine injection) manufactured by Boehringer Ingelheim / Lilly currently has “tentative” approval with FDA, for which final approval has been delayed due to ongoing patent litigation. And, Novo Nordisk has recently submitted a new drug application (NDA) for Xultophy which is a once-daily combination of Tresiba and the Victoza (liraglutide) for treating type 2 diabetes. The FDA could approve Xultophy by mid-2016.
Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by regular mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Actual drug patent expiration dates and a availability of new medications are subject to change due to patent litigation, settlement agreements, additional patents, exclusivities, and final FDA approval. Distribution and availability of new medications at pharmacies may not occur immediately following FDA approval. Patients are advised to speak with their healthcare professional or pharmacist regarding appropriateness as well as actual availability. All trademarks are the property of their respective owners.
*This is provided for information only. The reference to any medication above does not mean the medication is covered by your plan.