Teva Pharmaceutical Industries Ltd. (NYSE:TEVA) and Active Biotech (NASDAQ OMX NORDIC:ACTI) announced today that the Committee for Medicinal Products for Human Use (CHMP) confirmed its January 23, 2014 opinion to recommend against approval for the treatment of relapsing-remitting multiple sclerosis (RRMS) in the European Union (EU) at this time.
Both companies remain committed to the NERVENTRA
(laquinimod) clinical development program for multiple sclerosis (MS) and are focused on evaluating the CHMP feedback to determine potential next steps.
“We are disappointed with the outcome of the re-examination and will be working with the EMA to make NERVENTRA available to multiple sclerosis patients in the EU,” said Michael Hayden, President of Global R&D and Chief Scientific Officer. “We believe NERVENTRA has a favorable risk-benefit profile and the potential to fulfill an unmet need for a treatment that decreases disability progression, and protects against brain volume loss, two important goals in the management of MS.”
To further confirm the benefits of NERVENTRA on disability progression, Teva is conducting the CONCERTO trial, the largest MS trial with disability progression as the primary endpoint. The ongoing CONCERTO trial is the third Phase III study in RRMS and explores daily doses of NERVENTRA 0.6 mg and 1.2 mg. In addition, Teva is investigating the potential of NERVENTRA in progressive forms of MS. The first trial for this indication is planned to be initiated soon.
NERVENTRA is a once-daily oral, investigational, CNS-active immunomodulator with a novel mechanism of action being developed for the treatment of relapsing-remitting MS (RRMS) and progressive forms of MS. In extensive non-clinical and clinical studies, NERVENTRA has demonstrated both anti-inflammatory and neuroprotective properties and effects that have been shown to provide clinically meaningful results. The global Phase III clinical development program evaluating NERVENTRA in MS includes two pivotal studies, ALLEGRO and BRAVO. A third Phase III NERVENTRA trial, CONCERTO, is evaluating two doses of the investigational product (0.6mg and 1.2mg) in approximately 2,100 patients for up to 24 months. The primary outcome measure will be time to confirmed disability progression as measured by the EDSS, making CONCERTO the largest MS clinical trial with disability progression as the primary endpoint.