Laquinamod receives FDA fast track status
Submitted by art on Tue, 2009-04-07 06:42.
Oral laquinimod, an investigational treatment for RRMS, has received a Fast Track designation from the FDA. Teva completed enrollment for the first of its two Phase III clinical trials for laquinimod (ALLEGRO) in November 2008 and is currently enrolling RRMS patients globally for the second Phase III study (BRAVO).
Drugs designated for Fast Track are intended for the treatment of a serious or life-threatening condition and have demonstrated the potential to address unmet medical needs. Fast Track designation can potentially facilitate development and expedite the review process. This may allow the drug to enter the market as soon as late 2011.