Teva Pharmaceutical and Active Biotech has announced that the Committee for Medicinal Products for Human Use’s confirmed its earlier opinion to recommend against approval for the treatment of relapsing-remitting multiple sclerosis in the European Union at this time.
According to a statement from Active Biotech, 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. 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,” said Michael Hayden, President of Global R&D and Chief Scientific Officer at Teva.
Teva is conducting the CONCERTO trial to further confirm the benefits of NERVENTRA on disability progression. The ongoing trial is the third phase III study in RRMS. In addition, Teva is investigating the potential of NERVENTRA in progressive forms of MS with the first trial planned to be initiated soon.