Market Overview

UPDATE: ARIAD Says Pausing Enrollment in Studies of Iclusig

ARIAD
Pharmaceuticals, Inc. (NASDAQ: ARIA) today announced results of its
review of updated clinical data from the pivotal PACE trial of Iclusig®
(ponatinib) and actions that it is taking following consultations with
the U.S. Food and Drug Administration (FDA).

With a median follow up of 24 months, serious arterial thrombosis
occurred in 11.8% of Iclusig-treated patients: cardiovascular events
6.2%, cerebrovascular events 4.0% and peripheral vascular events 3.6%
(some patients had more than one type of event). This compares to 8.0%
after 11 months of follow up reflected in the current U.S. prescribing
information.

See full press release

Posted-In: News FDA

 

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