Exenatide tQT Study Showed No Prolongation of QT Interval
July 07 2011 - 5:23PM
Business Wire
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.1 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%
confidence interval for placebo-corrected, baseline subtracted QTc
being
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