Teva Pharmaceutical Industries has revealed that it will not be filing for US approval of its multiple sclerosis drug laquinimod in the near future.
Teva chief executive Shlomo Yanai noted that the company met with the US Food and Drug Administration last week to discuss the New Drug Application for the late-stage oral MS drug and following the meeting, he said "we now believe that it would be premature to file the NDA at this time". Mr Yanai added that "the FDA has offered to work with us to determine the best design for conducting an additional trial".
Mr Clark told PharmaTimes World News that the decision to put the submission on hold was "prudent". In August, initial results from the Phase III BRAVO study, the second of two late-stage trials on laquinimod, showed that the drug failed to meet its primary endpoint of reducing the annualised relapse rate when compared with placebo.... Read More - http://www.msrc.co.uk/index.cfm/fuseact ... ageid/1735