SAN DIEGO, INDIANAPOLIS, and WALTHAM, Mass., July 7,
2011 /PRNewswire/ -- Amylin Pharmaceuticals, Inc. (Nasdaq:
AMLN), Eli Lilly and Company (NYSE: LLY) and Alkermes, Inc.
(Nasdaq: ALKS) today announced results from a thorough QT (tQT)
study that assessed the potential of exenatide to increase the QT
interval across a wide range of plasma concentrations. The study
was conducted to satisfy a requirement by the U.S. Food and Drug
Administration (FDA) in support of the New Drug Application (NDA)
for BYDUREON™ (exenatide extended-release for injectable
suspension), an investigational medication for type 2 diabetes.
Using multiple heart rate correction methodologies, the study met
the pre-specified primary endpoint, demonstrating that exenatide at
and above therapeutic levels did not prolong the corrected QT (QTc)
interval in healthy individuals. Further, the study found no
relationship between QTc interval and plasma exenatide
concentrations.
The QT interval represents the amount of time the heart's
electrical system takes to repolarize, or recharge, after each beat
(i). As prolongation of the QT interval may increase the risk for
cardiac arrhythmias, the FDA requires a tQT study for most new
drugs in development. A tQT study is a specialized clinical trial
designed to assess whether an investigational medication has the
potential to prolong the QT interval.
"The findings of this tQT study are clear. Exenatide did not
lead to QT prolongation, even at very high concentrations in the
blood," said Christian Weyer, M.D.,
senior vice president, research and development, Amylin
Pharmaceuticals. "This study was designed in accordance with
existing guidelines and in consultation with the FDA. We are
confident in these results and will continue to work toward making
BYDUREON available to patients in the U.S. as soon as
possible."
In its October 2010 complete
response letter, the FDA requested a tQT study with exposures of
exenatide at higher than typical therapeutic levels of BYDUREON,
such as those that might be achieved in patients with impaired
renal function. The companies plan to submit results of the tQT
study to the FDA in the third quarter of 2011 as part of their
reply to the complete response letter for the BYDUREON NDA.
Study Details
This randomized double-blind study, designed in accordance with
the FDA's published guidance on clinical evaluation of QT/QTc
interval (ICH E14), compared the effects of exenatide at or above
therapeutic concentrations to placebo on the QT interval in
approximately 75 healthy volunteers. The primary endpoint was to
determine whether exenatide administered at therapeutic and
supratherapeutic concentrations differed from placebo in the mean
change in the QTc interval (defined as the upper bound of the 95
percent confidence interval for placebo-corrected, baseline
subtracted QTc being