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Lots of dosing data wins over FDA panel for Boehringer's olodaterol LABA in COPD
Over the LABA hurdle
Monday, February 4, 2013
Generally positive comments from FDA reviewers and a panel's overwhelmingly positive vote for olodaterol to treat chronic
obstructive pulmonary disorder probably speak less about a change in U.S.
regulators' views about LABA safety than they do about the heft of Boehringer
Ingelheim GmbH's application.
By designing a robust clinical
development program for olodaterol that included multiple studies designed to
show a clear dose response, Boehringer sidestepped the problems that caused FDA
to send the last long-acting adrenergic receptor beta 2 it reviewed back to the
drawing board to establish the lowest effective dose.
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