EU Advisory Panel Recommends Not to Approve MS Drug by Teva, Active Biotech

Teva Pharmaceutical Industries Ltd. and Active Biotech report that the Committee for Medicinal Products for Human Use of the European Medicines Agency (EMA) confirmed its January 23, 2014 opinion to recommend against approval in the European Union Nerventra (laquinimod) for the treatment of relapsing-remitting multiple sclerosis. Neventra is a once-daily oral, investigational, central nervous system-active immunomodulator.

In a statement, the companies said they \remain committed to the clinical development program for Nerventra 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,” said Michael Hayden, president of Global R&D and chief scientific officer for Teva, in a company statement. “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.”

Teva is conducting a Phase III study, Concerto, to examine disability progressions as the primary endpoint. The ongoing Concentro trial is the third Phase III study in RRMS and explores daily doses of Nerventa 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.

Source: Teva Pharmaceutical Industries


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