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Home / Letter From The Editor / Editor’s Note, DCMS # 123: Two New Insulins Delayed

Editor’s Note, DCMS # 123: Two New Insulins Delayed

Feb 11, 2013

Typically this clinical letter focuses on articles related to patient disasters averted, medical slides and clinical texts. However I am going to make an exception this week and share information from Novo Nordisk on the approval process for two new insulins. These ultra long insulins had a good chance of helping more of our patients achieve their targets with less risk of hypoglycemia.

The complete response letter from FDA requests additional cardiovascular data from a dedicated cardiovascular outcomes trial before the review of the New Drug Applications for new long acting insulins Tresiba® and Ryzodeg® can be completed.

Novo Nordisk is evaluating the content of the Complete Response Letter and will work closely with the FDA to provide the requested data. Novo Nordisk does not expect to be able to provide the requested data during 2013.

It appears that it will be at least another year before these two insulins get to market.

Often times we have men with diabetes who have problems with ED and they are given prescriptions for sildenafil. This week’s Disaster Averted looks at what can happen if our patients drink grapefruit juice while using this drug. Our current intern, Sara Dempsey, PharmD candidate from LECOM, also found that low testosterone can cause ED problems and she has prepared a set of Homerun Slides showing how this happens, what other symptoms might indicate low testosterone, and current treatment options.

Our Clinical Text is focused on Sick-Day Rules in Diabetes and includes epidemiology, causes, diagnosis and clinical management, and our Mastery In Minutes video interview is with Dr. Oded Langer, Columbia University, who is doing ground-breaking work on the safety of oral medications for pregnant women.