Laquinimod Misses Key Study Goal - Drug Discovery and Development

NEW YORK (AP) – Teva Pharmaceutical Industries Ltd. said its experimental drug laquinimod, an oral treatment for multiple sclerosis, did not reduce patients’ annual relapse rate in a late-stage clinical trial.

The results showed that laquinimod was not more effective than a placebo. The study involved 1,331 patients who were treated with one of three options: laquinimod, a placebo, or Avonex, an older MS drug made by Biogen Idec Inc. The patients were assigned to the treatment groups at random. However, Teva said MRI scans showed the patients in the laquinimod and Avonex groups had more brain lesions, which indicates they had more severe multiple sclerosis.

The company said the patients in the laquinimod and Avonex groups had more overall lesions, and they had a greater number of recent lesions. Teva said if the study results are adjusted to remove the imbalance in the number of lesions, laquinimod met its main goal of lowering the relapse rate, and it also reduced brain volume loss and disability.

Teva and its partner Active Biotech said they still plan to seek approval of laquinimod in the U.S. and the European Union. In December, the companies said laquinimod met its main goal in its first late-stage trial. The companies said patients who took the drug were less likely to have a flare-up of the disease during treatment than patients who took a placebo. Patients who took laquinimod also reported less disability from the disease.

Teva also makes Copaxone, the top-selling multiple sclerosis therapy in the world. The Israeli company is the world’s largest seller of generic pharmaceuticals.

Date: August 1, 2011
Source: Associated Press