LUND, SWEDEN, Jul 17, 2012 — Active Biotech today announced that the European Medicines Agency (EMA) has completed the validation process for the marketing authorization application (MAA) of the medicinal product laquinimod for the treatment of relapsing-remitting multiple sclerosis (RRMS).
The completion of the MAA validation process and acceptance for review now leads to the formal scientific review process by EMA’s Committee for Medicinal Products for Human Use.
This acceptance of the EMA filing for review triggers a milestone payment of USD 5 million to Active Biotech from Teva.
The MAA submission is supported by a pooled analysis of data from the two global Phase III clinical trials in RRMS involving more than 2,400 patients treated for two years, the ALLEGRO and BRAVO trials. This analysis further strengthens the positive results achieved in the studies.
Additionally, Active Biotech and Teva continue to work with the Food and Drug Administration to determine the regulatory path forward for laquinimod in the U.S.
ABOUT LAQUINIMOD
Laquinimod is an oral, once-daily CNS-active immunomodulator with a novel mechanism of action being developed for the treatment of MS. In animal models laquinimod crosses the blood brain barrier to potentially have a direct effect on resident CNS inflammation and neurodegeneration. The global Phase III clinical development program evaluating oral laquinimod in MS includes two pivotal studies, ALLEGRO and BRAVO.
In addition to the MS clinical studies, laquinimod is currently in Phase II of development for Crohn’s disease and Lupus.
..
Please note that all comments are moderated.
So that you can be kept up to date with MS information
Become a Member of MS Views and News
Become a Member of MS Views and News
~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~
Visit our MS Learning Channel on YouTube: http://www.youtube.com/msviewsandnews