Step One Complete
Late yesterday we learned that the FDA has
approved Byetta as a monotherapy. According to a press release issued by Amylin
(NASDAQ:AMLN) and Lilly (NYSE:LLY) besides receiving approval as a monotherapy Byetta
will also get a label change. The release states; “In addition to the monotherapy indication, the FDA approved
changes to the BYETTA Prescribing Information to incorporate updated safety
information, including pancreatitis-related language added to the Warnings and
Precautions section. This update addresses the alert issued by the FDA in
August 2008. The new label also expands upon existing language regarding use of
BYETTA in patients with renal impairment.”
This news is just the first in a series of
events that Diabetic Investor previously outlined after Amylin reported their
earnings. Next on the list will be the FDA approving Victoza® and that will be
followed by approval of Byetta LAR. As we noted before the key that unlocked
the Byetta approval was getting the correct label language, language that will
appear with all GLP-1 products.
Looking towards the future the stage is now
set for a what will surely be one of the more interesting marketing battles between
Novo Nordisk (NYSE:NVO), Lilly and Amylin. Considering the comments made by Novo
during their earnings call last week the company seems to be positioning
Victoza as a diabetes/obesity drug rather than just a straight diabetes drug.
They understand that they have a limited window of opportunity with Victoza as
physicians and patients will prefer the once-weekly dosing option of Byetta LAR
over the once daily dosing option for Victoza.
With the heightened interest in GLP-1
therapy the diabetes drug market is about to undergo a transformation. Things
are about to get very interesting. Very interesting indeed!