EMA starts scientific review of Laquinimod
Posted: Thu Jul 19, 2012 1:10 am
EMA starts scientific review of Laquinimod in relapsing-remitting Multiple Sclerosis
Active Biotech 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.... Read More - http://www.msrc.co.uk/index.cfm/fuseact ... ageid/1735
Active Biotech 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.... Read More - http://www.msrc.co.uk/index.cfm/fuseact ... ageid/1735