FDA Revokes SPA for Laquinimod in Phase III MS Trial

FDA rescinded a Special Protocol Assessment for a Phase III trial of laquinimod, developed by Active Biotech and Teva Pharmaceutical Industries for multiple sclerosis and Huntington’s disease.

In January, the highest dose arms in two MS trials were discontinued, following the recommendation of a data monitoring committee. In February, Teva submitted an amendment to the SPA regarding the change. FDA took back the SPA because, under its regulations, all changes must be agreed to prior to implementation. This requirement could not be fulfilled, the companies said, because the data monitoring committee’s recommendation triggered immediate action to withdraw the 1.2 mg dose from the trial.

No change is anticipated in the trial's completion date, and the trial continues to evaluate the daily 0.6 mg dose compared to placebo. Teva plans to use the trial to support filing for marketing approval for laquinimod in the U.S. and the European Union.