The FDA was none too happy with Orexigen ($OREX) when it put out some early positive cardio data for obesity drug Contrave in March. One reason? Early data can be misleading--and now, it looks like that might have been the case for Contrave.
Tuesday, the California biotech and marketing partner Takeda announced they were shutting down a 9,000-patient cardio outcomes study after sharing rosy results from the 25% mark. Despite longtime concerns that weight-loss drugs can cause heart damage, that interim analysis suggested the therapy could actually reduce major adverse cardiac events.
After the pair nixed the trial, though, the Cleveland Clinic-led exec committee in charge of the study released the results from the 50% mark--and those didn't look so good, Forbes reports.
At the 25% mark, 59 patients in the placebo group recorded major cardiovascular events--including heart attacks and strokes--versus 35 from the Contrave arm. But as the next 25% showed, 43 placebo-takers experienced major events compared with 55 participants on Contrave.
Put it all together, and Contrave only posted a 12% decrease--one that's no longer statistically significant--and could have completely disappeared had the study gone on, Forbes points out. And because Contrave raises blood pressure--which takes time to result in heart attacks or strokes--it's still possible the med ups patients' CV risk.
It's bad news for Orexigen, which analysts at first thought might have a marketing advantage in a competitive field. After the data leak, Leerink Partners analyst Paul Matteis wrote in a note to clients that healthcare providers' opinions of the treatment had "improved significantly" in light of the early findings.
|Cleveland Clinic's Steve Nissen|
Now, though, the company will have to find another way to help Contrave stand out over rivals Qsymia from Vivus ($VVUS) and Belviq from Arena ($ARNA). Some analysts predict it eventually will: Wells Fargo's Matthew Andrews has said he sees Contrave generating $634 million in 2020 sales which measures up to forecasts of $481 million for Belviq and $396 million for Qsymia.
And Orexigen will have to pony up for a new CV outcomes trial to satisfy the FDA's post-marketing requirements. According to The Wall Street Journal, the new study will launch later this year and wrap up in 2022. The Cleveland Clinic's Steve Nissen, who lambasted the company for releasing interim data, confirmed that he will also head up the new study.
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