Oral Laquinimod Unfortunately on hold

Teva chief executive Shlomo Yanai also caused a bit of a stir by revealing that the company is holding off on filing laquinimod, developed with Sweden’s Active Biotech, in the USA.

He 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.

However, at the time, Teva noted that the placebo and treatment study groups showed dissimilarity “in two baseline magnetic resonance imaging” characteristics and following a “pre-specified sensitivity analysis”, when this imbalance was corrected, laquinimod demonstrated a significant reduction in the annualised relapse rate (21.3%) in the risk of disability progression and in brain volume loss (27.5%).

In the summer, the company still felt confident that an adjustment of the data would be enough to support a filing but Mr Clark said “this was not something upon which we expected the FDA would look favourably”. That, “in conjunction with the lack of overwhelmingly positive data previously”, led the analyst to “remove estimates for laquinimod from our model some time ago”. Mr Clark concluded by praising Teva management’s decision “to deploy their resources in the most sensible way possible and, for now, that means holding off on laquinimod”.