Tag Archives: URLi

Lyumjev (ultra-rapid lispro) Label Analysis and Supply Conversion Thoughts

Last week, FDA approved Lilly’s ultra-rapid lispro as “Lyumjev,” pronounced [LOOM-jehv] as the second ultra rapid-acting injectable insulin behind Novo’s Fiasp. Of note, the generic name for Lyumjev is lispro-aabc. Below, FENIX provides an in-depth Lyumjev label analysis, including a comparison with Novo on RAI supply conversion strategy, and potential insights into Lilly’s connected pen solution.

This content is for members only.
Register
Already a member? Log in here

Lilly’s Lyumjev FDA Approved (ultra-rapid lispro)

Today, FDA posted a label for Lyumjev (ultra-rapid lispro) in the Drugs@FDA database ahead of a Lilly press release (see direct link here to the label in PDF). FENIX will have a full label analysis in the coming days.

This content is for Read Less members only.
Register
Already a member? Log in here

Rybelsus and URLi Receive Positive CHMP Opinions

Two important positive CHMP opinions were received this week for Novo Nordisk’s Rybelsus and Lilly’s ultra-rapid lispro product (to be branded as Liumjev). Below, FENIX provides thoughts on the positive CHMP opinions including insight into the ongoing US FDA review of Lilly’s URLi.

This content is for Read Less members only.
Register
Already a member? Log in here

Lilly to Invest $400M in Diabetes Manufacturing

Lilly announced plans to invest $400M in its Lilly Technology Center campus in Indianapolis. The capital investment is said to include enhancements to existing manufacturing facilities that make Lilly insulin, expanding capacity for other marketed diabetes products, and initial capital investments for future medicines. Below, FENIX provides brief thoughts on Lilly’s investments including insights into which products are likely benefiting.

This content is for Read Less members only.
Register
Already a member? Log in here

New Ph1 LY900027 RAI Compound Could Be For Closed Loop

A Ph1 trial for a new Lilly compound (LY900027) has been observed on CT.gov. Below, FENIX provides thoughts on what the potential MOA could be particularly given the similarity in compound ID with Lilly’s ultra-rapid-acting insulin lispro (URLi), LY900014.

This content is for Read Less members only.
Register
Already a member? Log in here