Teva Pharmaceutical Industries and Active Biotech have announced 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 in the European Union at this time.
Both companies remain committed to the Nerventra (laquinimod) clinical development programme for multiple sclerosis 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,” says Michael Hayden, president of Global R&D and chief scientific officer. “We believe Nerventra has a favourable risk-benefit profile and the potential to fulfil an unmet need for a treatment that decreases disability progression, and protects against brain volume loss, two important goals in the management of multiple sclerosis.”
To further confirm the benefits of Nerventra on disability progression, Teva is conducting the CONCERTO trial, the largest multiple sclerosis trial with disability progression as the primary endpoint. The ongoing CONCERTO trial is the third phase III study in relapsing-remitting multiple sclerosis and explores daily doses of Nerventra 0.6mg and 1.2mg. In addition, Teva is investigating the potential of Nerventra in progressive forms of multiple sclerosis. The first trial for this indication is planned to be initiated soon.