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Roche will seek approval of its multiple sclerosis pill after the asset succeeded in a third Phase 3 trial. But the study also found liver side effects, including one case of the worrying liver damage signal known as Hy’s Law, and there was an unexplained imbalance in the death rate.
These findings could imperil the drug’s chances of gaining approval, and even if it does, its market uptake could be limited.
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