Better late than never for exenatide + glargine?

The year was 2005, Gwen Stefani’s “Hollaback Girl” was the #1 song, “Million Dollar Baby” had just won Best Picture, and Byetta was approved by the FDA.  It was a landmark moment for Amylin Pharmaceuticals who just weeks before had received approval for Symlin.

Byetta was launched with very good data, the “Three AMIGO” trials which were the key data in the FDA submission, which showed efficacy and safety on the background of SFU, MET, or SFU+MET, but absent one key piece of data and indication.

When I was promoting Byetta in my former account management role, from day 1 of Byetta availability, the first question anyone asked would be “what about Byetta+glargine?”  To which we would say, not indicated, sign here and someone will get you some data on the subject eventually, or maybe not.

Most high prescribing Byetta physicians have always used Byetta + glargine together.   Although not an “approved indication” the combination has always been a physiologic fit that practitioners figured out very early.  Around the same time,  Amylin/Lilly took an interesting strategic move by trying to “battle” glargine, vs. what the marketing academics might call “coopetition”.  Several non-inferiority studies were done against glargine, read here and here.  Would a better approach have been less of a “Red Ocean” (us vs. them) mentality and a move to a “blue ocean” approach?  It is easy to play-armchair brand strategist now, but were there signals early on that leadership were ignoring?

So why now? 6.5 year later and they finally have an indication?  Will this effect any prescribing?  Our gut instinct is no, this is very, very old news, and would have been helpful some years ago.  But now? does it matter?  and what would could this mean for Bydureon?

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