GSK said today that a massive phase 3 trial of a as soon as highly-promising drug had failed to meet its major endpoint. Final 12 months the firm announced that one more phase 3 trial with the exact same drug had failed. GSK mentioned it would “further analyse the information and far better recognize the findings” but that, for now at least, it would not seek regulatory approval for the drug.
The SOLID-TIMI 52 (Stabilisation Of pLaques Making use of Darapladib – Thrombolysis In Myocardial Infarction 52) trial randomized a lot more than 13,000 sufferers inside of thirty days of an acute coronary syndrome to acquire both placebo or darapladib, an anti-inflammatory drug designed to stabilize atherosclerotic plaques. GSK reported right now that the drug did not drastically decrease major coronary events. The complete benefits of the trial will be presented at a potential scientific meeting.
Last November GSK announced that the STABILITY trial (STabilisation of Atherosclerotic plaque By Initiation of darapLadIb Treatment) had failed to meet its principal endpoint. In that trial darapladib was in contrast to placebo in more than 15,000 patients with persistent coronary heart condition. The primary final results of the trial had been then presented in March at the American College of Cardiology and published concurrently in the New England Journal of Medicine.
GSK stated that the two trials had uncovered “no significant safety concerns” with the drug. But an ongoing situation has been that darapladib brings about unpleasant odors of feces and urine in some folks taking the drug. This prompted 1 reporter, Matt Herper, to label darapladib a “stinkbomb of a drug.” But unless growth of the drug resumes this will no longer pose a problem for GSK, of course.
Darapladib was originally produced by Human Genome Sciences. It was a essential purpose why GSK acquired that firm.
Strike 2 For After Promising GSK "Stinkbomb" Heart Drug
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