Billions of dollars hinge on the definition of amino acid vs protein

[SwampNut]

This is about Retatrutide, the next-generation GLP-1/GIP/Glucagon triple agonist, that I've been using for a year or so.  The trials are done, it's well proven for blood sugar control as well as weight loss, and will be released soon.  But it's already in use by millions of us, on the gray market and via compounding.  Eli Lilly wants to stop the compounding (they can't stop the gray market). 

 

The method they are trying to use is this:

 

The GLP-1 medications have been classified as peptides, not biologics; peptides that are FDA approved are considered drugs and allowed to be compounded if legal requirements for compounding have been met. Lilly has argued that retatrutide should instead be considered a protein; proteins and products that are “analogous” to proteins are included under the definition of “biological products” in the amended Public Health Service Act.

 

A requirement for an agent to be classified as a biologic is that it must be greater than 40 amino acids in size. Lilly says that this particular GLP-1 has 41 amino acids,” Dr. Rumore said. Lilly describes retatrutide as having a backbone chain of 39 alpha amino acids connected via an isopeptide bond to a second backbone chain that has two or more amino acids, one of which is an alpha amino acid and one of which is not. The FDA determined that only alpha amino acids are counted toward the “greater than 40 amino acids” threshold, and further ruled that retatrutide did not qualify as “analogous to a protein” either, because it did not share the “fundamental defining property of a protein [of] being greater than 40 alpha amino acids.”

 

 

 

https://www.pharmacypracticenews.com/Policy/Article/04-25/GLP-1-Lilly-FDA-Lawsuit/76663?omnisendContactID=6615b0d5671207aff36a8954