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FDAnews Drug Daily Bulletin

CHMP Says No to Teva and Active Biotech’s Nerventra

Jan. 29, 2014

The European Medicines Agency’s Committee for Medicinal Products for Human Use has recommended against marketing authorization for Teva and Active Biotech’s Nerventra for relapsing-remitting multiple sclerosis, saying the benefits don’t outweigh the risks.

In an opinion issued last week, the committee concluded that “the benefits of Nerventra in patients with relapsing-remitting MS do not outweigh the potential risks” of increased incidences of cancers and potential birth defects, both seen in animal studies. Teva also neglected to assure the committee that it had a plan to prevent pregnancies in women taking Nerventra (laquinimod), the opinion notes.

“Both companies remain committed to Nerventra … and will continue to liaise closely with the EMA in working to make Nerventra available as a new treatment option for patients with RRMS in Europe,” a joint statement by Teva and Active Biotech says. They said they will request a reexamination.

Nerventra is thought to work by modulating the immune system to control inflammation and damage to nerves. A Phase III study of the drug for MS has been completed and two more are in progress, Teva said. Nerventra is also being evaluated for Crohn’s disease and lupus, with plans to expand to other neurodegenerative diseases such as Huntington’s, the company said. — Lena Freund

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