Phase III
“Reaching this pre-specified clinical endpoint is an important milestone that brings us one step closer to a potential regulatory submission in both the U.S. and Europe for valoctocogene roxaparvovec to treat adults with severe hemophilia A,” stated Hank Fuchs, president of Worldwide Research and Development at BioMarin.
The patients receiving Lyrica didn’t show a statistically significant reduction in seizure frequency compared to placebo.
The agency expressed concern over the results of recently finished studies in rats and dogs that showed central nervous system events that might have implications in humans.
Here’s a roundup of some of the top clinical trial news from the previous week.
Despite hitting endpoints in the late-stage trial, BioCryst’s BCX7353 results do not stack up against Takeda’s Takhzyro, which was approved last year.
Germany-based Boehringer Ingelheim announced that its SENSCIS Phase III clinical trial met its primary endpoint, which was reduction in the annual rate of decline in forced vital capacity.
Merck & Co. announced that its Keytruda failed to hit its primary endpoint in the Phase III Keynote-119 clinical trial. The primary endpoint was superior overall survival compared to chemotherapy.
Here’s a roundup of some of the top clinical trial news from the previous week.
An Independent Data Monitoring Committee recommended the trial be stopped because of lack of survival benefit for patients receiving the drug compared to placebo.
Patients were randomized 1:1 to receive Nerlynx and Xeloda or Tykerb and Xeloda. Co-primary endpoints were progression-free survival and overall survival.
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