FDA grants fast-track status to Teva’s new multiple sclerosis drug A new oral treatment for multiple sclerosis, licensed to Teva Pharmaceutical Industries, has been granted “fast track” designation by the US Food and Drug Administration (FDA). The designation, intended for the treatment of a serious or life-threatening condition, will allow the Israeli giant to speed up the review process, enabling it to get the drug, Laquinimod, to market possibly as early as 2011.
Teva is now involved in two Phase III clinical trials of the drug, the first began in November last year, and the company is now enrolling patients for the second.
Laquinimod was developed by Active Biotech and licensed to Teva in 2004. It is an oral drug, taken once a day, and is being developed as a disease modifying treatment for relapsing/remitting multiple sclerosis. Results from Phase II clinical trials showed that an oral dose of the drug significantly reduced multiple sclerosis activity by a median of 60 percent compared to a placebo.