Heart Incidents End Parts of Two Studies by Teva, Active Biotech
04 Janvier 2016 - 5:50PM
Dow Jones News
Teva Pharmaceutical Industries Ltd. and Active Biotech AB said
Monday they were ending the higher-dose portions of two
multiple-sclerosis studies with the drug Laquinimod after eight
patients suffered nonfatal cardiovascular events.
The companies said the incidents occurred in the higher-dose
components of a phase 3 and a phase 2 clinical trial. The
lower-dose and placebo components of the tests will continue.
Phase 3 clinical trials are typically the last phase before a
drug gets approval from the U.S. Food and Drug Administration.
Teva shares fell 1.3% in early trading in New York, and Active
Biotech shares fell by about one-third in Stockholm.
Laquinimod is a once-daily oral drug being developed for
treating multiple sclerosis and Huntington disease.
The stoppage occurred after the studies' data-monitoring
committee noticed an imbalance in the number of heart incidents in
the higher-dose trials and those of the lower-dose and placebo
trials.
Teva said there aren't "cardiovascular concerns" for the lower
dosage of Laquinimod in large trials it had previously completed
and in continuing long-term extensions studies.
Write to Austen Hufford at austen.hufford@wsj.com
(END) Dow Jones Newswires
January 04, 2016 11:35 ET (16:35 GMT)
Copyright (c) 2016 Dow Jones & Company, Inc.
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