The regulator placed a partial clinical hold on Roche’s fenebrutinib—being developed for relapsing MS—after two patients experienced elevated hepatic transaminase and bilirubin levels indicative of liver injury.
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The company stated that its multiple sclerosis drug candidate, part of a class of compounds that has been linked to cases of liver damage, reduced brain lesions in a mid-stage trial and that no new safety concerns emerged.
Novartis said no signs of liver damage had been seen in trials testing its anti-inflammatory drug candidate remibrutinib so far, voicing cautious optimism that it could elude the side effects that have beset rival products in the same drug class.
Merck KGaA said on Wednesday the U.S. Food and Drug Administration (FDA) had paused the initiation of new patients on its multiple sclerosis evobrutinib drug, knocking the German drugmaker’s share price.
