Takeda Development Center Americas, a unit of Japan's Takeda Pharmaceutical, and Orexigen Therapeutics ($OREX) have ended a cardiovascular outcomes trial that compared the obesity drug Contrave to a placebo in addition to diet and exercise counselling, in 8,909 overweight and obese patients with certain CV risk factors, the companies said.
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| Steven Nissen |
A May 12 release said the companies accepted the recommendation of the Executive Steering Committee chaired by Dr. Steven Nissen of The Cleveland Clinic, for early termination.
"The Light Study is not being terminated due to a finding of superiority or harm," according to the release. "The ESC, Takeda and Orexigen expect to report the final Light Study data in a scientific forum after all of the CV events in the Light Study have been collected and properly adjudicated."
According to the release, a separate trial linked to the approval of Contrave remains on track.
"At the time of United States (U.S.) approval of Contrave in September 2014, the U.S. Food and Drug Administration (FDA) required a new CV outcomes trial as a post-marketing requirement (PMR) for the evaluation of the effects of long-term treatment with Contrave on the incidence of major adverse cardiovascular events (MACE) in overweight and obese subjects with CV disease or multiple CV risk factors," the release said.
"This new CV outcomes trial is expected to begin later this year and has a target completion date of 2022."
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| Takeda CEO Christophe Weber |
Takeda has moved at a brisk pace on a number of fronts in drug development since Christophe Weber took over as CEO this year.
Last week, Sumitomo Dainippon Pharma and Takeda Pharmaceutical canceled a four-year-old license and development agreement aimed at commercialization of lurasidone hydrochloride (Latuda) products. The decision follows disappointing Phase III trials to treat schizophrenia announced last month.
The two companies said in a news release, however, that the clinical results did not drive the decision.
"The termination of the agreement is based on market and business considerations of Takeda and is not the result of new safety or efficacy information on Latuda," the joint release said.
- here's the release