Humulin®

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CONNECTED CARE: Connected-Pen Approval

The Connected-Pen has been approved by the FDA.

Detailed Information

The FDA approved the supplemental NDA for Lilly's newest insulin pen, for Lilly's Connected Care pen-based platform.

The Connected Care pen is a modified version of Lilly’s existing prefilled, disposable Pen and will be compatible with insulins in Lilly’s suite of DM treatments. The Connected Care pen is approved for use with IL-100 and IG-100. Our goal is to incorporate our future insulins into the Connected Care pen-based platform as well.

The Connected Care pen is intended to be part of Connected Care pen-based platform, currently under development. Lilly does not intend to launch the Connected Care pen separately from the pen-based platform.

Lilly is working with the FDA to determine regulatory requirements for additional components of the platform including the attachment which will transmit insulin dosing data from the Connected Care pen to the mobile app.

The attachment is a Bluetooth-enabled module that will transmit insulin dosing data from the Connected Care pen to the mobile app.

A mobile app is currently in development. The mobile app will

  • log glucose and insulin data,

  • log meal details and other health-related information, and

  • include insulin dosing reminders.

The goal is to integrate these data in future iterations of the Connected Care pen-based platform to provide personalized insulin dose recommendations.

Glossary

DM = diabetes mellitus

FDA = Food and Drug Administration

IG-100 = insulin glargine 100 units/mL

IL-100 = Humalog® (insulin lispro injection) 100 units/mL

Lilly = Eli Lilly and Company

NDA = New Drug Application

Pen = KwikPen®

Date of Last Review: November 22, 2019

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