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news.European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has rejected the development of Nerventra (Laquinimod) for the treatment of relapsing-remitting multiple sclerosis (RRMS) by Israel-based Teva Pharmaceutical and Swedish biotechnology firm Active Biotech.
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The two firms said they are committed to the Nerventra clinical development program for multiple sclerosis (MS) and are focused on evaluating the CHMP feedback to determine potential next steps.
Teva president of Global R&D and chief scientific officer Michael Hayden said the company is 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," Hayden said.
Teva is also carrying out the CONCERTO trial, the largest MS trial with disability progression as the primary endpoint, in order to further confirm the benefits of Nerventra on disability progression.
The ongoing CONCERTO trial is the third Phase III trial in RRMS and explores daily doses of Nerventra 0.6mg and 1.2mg.
Additionally, Teva is investigating the potential of the drug in progressive forms of MS.
According to the company, the first trial for this indication is planned to be started soon.