Europe’s Committee for Medicinal Products for Human Use: The risk-benefit profile of laquinimod is not favorable at this time.
Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) and Active Biotech (NASDAQ OMX NORDIC: ACTI) announced today that both companies remain committed to the NERVENTRA (laquinimod) clinical development program for multiple sclerosis (MS) following the announcement of a negative opinion for the treatment of relapsing-remitting multiple sclerosis (RRMS) by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA).
The CHMP has concluded that the risk-benefit profile of NERVENTRA is not favorable at this time. In accordance with European regulations, Teva and Active Biotech intend to request a re-examination of the CHMP opinion.
Teva and Active Biotech are focusing on evaluating the CHMP’s review and will continue to liaise closely with the EMA in working to make NERVENTRA available as a new treatment option for patients with RRMS in Europe.