Both companies remain committed to the clinical development program for multiple sclerosis (MS) and will evaluate the CHMP feedback to determine potential next steps. To confirm the benefits of the drug on disability progression, Teva is conducting the Phase III CONCERTO trial, the largest MS trial with disability progression as the primary endpoint. Teva is also investigating the potential of Nerventra in progressive forms of MS.
“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, Teva's 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.”