Although a filing of laquinimod in the USA was delayed at the end of last year, Teva Pharmaceutical Industries and Active Biotech say that their submission of the multiple sclerosis pill is progressing well in Europe.
The Swedish drugmaker has announced that the European Medicines Agency has completed the validation process for the firms' marketing authorisation application of laquinimod for the treatment of relapsing-remitting MS. This means that the formal scientific review by the EMA's Committee for Medicinal Products for Human Use can now begin, triggering a milestone payment to Active of $5 million.
The MAA is supported by a pooled analysis of data from the two Phase III trials involving more than 2,400 patients treated for two years, namely ALLEGRO and BRAVO. However, initial results from the later study showed that the drug failed to meet its primary endpoint of reducing the annualised relapse rate when compared with placebo.
This prompted Teva to announce in November that it would hold off on filing laquinimodin the USA. Following talks with the Food and Drug Administration, the Israeli firm decided it would be "premature" to submit a New Drug Application, noting that the agency offered to work with the company to determine the best design for conducting an additional trial.
In addition to MS, laquinimod is currently in Phase II for Crohn's disease and lupus.