Dear Valued Visitor,

We have noticed that you are using an ad blocker software.

Although advertisements on the web pages may degrade your experience, our business certainly depends on them and we can only keep providing you high-quality research based articles as long as we can display ads on our pages.

To view this article, you can disable your ad blocker and refresh this page or simply login.

We only allow registered users to use ad blockers. You can sign up for free by clicking here or you can login if you are already a member.

FDA’s Sanofi SA (ADR) (SNY) Delay Highlights Some Red Flags With IGlarLixi

Page 1 of 2

We just learnt that the FDA has pushed back its decision day on Sanofi SA (ADR) (NYSE:SNY)’s insulin combo candidate IGlarLixi. Markets haven’t moved too much on the news (at least, not yet), but there is a general air of surprise surrounding the delay.

Sanofi was pushing to get the product approved ahead of Novo Nordisk A/S (ADR) (NYSE:NVO) competing product, IDegLira, and spent a $245 million priority review voucher ahead of submission to that aim. Now it looks as though there’s going to be practically no difference between the two products’ review dates.

This isn’t the biggest worry for Sanofi, however. The issues that have led to the delay may, in turn, lead to the FDA declining the drug come PDUFA. Here’s why.

mri, doctor, physicians, display, treatment, idea, medic, experiment, pharmaceutical, patient, future, interface, laboratory, multimedia, intelligence, male, digital, scan,

Wichy/Shutterstock.com

The extension is rooted in the device used to administer the combination of insulin glargin and the GLP-1 receptor agonist Lixisenatide. It’s a pen type injectable, with a dial based dosing system. There are two pens available, each of which offer a different min-max dose range.

Here’s what they look like:

Pens

They are designed to deliver a dose based on a patient’s selecting of an insulin dose (as measured in units). The patient uses the scroll mechanism to select their insulin unit number and the pen automatically selects the corresponding dose of Lixisenatide. The yellow pen is a lower dose range (10U-40U) and is targeted at insulin naïve patients, and the green pen is higher dose range (30U to 60U) and targeting those who require higher daily dosing. That all seems relatively simple, right? Well, yes, until we look at the proposed labeling on the scroll system:

label

The company has gone for a seemingly strange black/white indication system, designed to show recommended dosing. Doses within the recommended dose range are black writing on white background. Doses below the recommended dose are white writing on black background. The point of this convoluted approach is to discourage dosing errors, but to us, it looks like there is considerable room for human error. The advisory panel agrees:

“It should also be noted that the numbers that are darkened on the pen dial are meant to represent doses that are not established as safe and effective and that should not be used. It is unclear whether this device design element will have the effect it is intended to have (i.e., preventing dosing errors) in the care setting.”

Follow Sanofi Aventis (NYSE:SNY)
Trade (NYSE:SNY) Now!

Page 1 of 2

Biotech Stock Alert - 20% Guaranteed Return in One Year

Hedge Funds and Insiders Are Piling Into

One of 2015's best hedge funds and two insiders snapped up shares of this medical device stock recently. We believe its transformative and disruptive device will storm the $3+ billion market and help it achieve 500%-1000% gains in 3 years.

Get your FREE REPORT and the details of our 20% return guarantee today.

Subscribe me to Insider Monkey's Free Daily Newsletter
This is a FREE report from Insider Monkey. Credit Card is NOT required.
Loading Comments...
X

Thanks! An email with instructions is sent to !

Your email already exists in our database. Click here to go to your subscriptions

Insider Monkey returned 102% in 3 years!! Wondering How?

Download a complete edition of our newsletter for free!