Merck KGaA's BTK inhibitor hit by partial clinical hold over safety concern, but PhIII readout unaffected
The FDA has slapped a partial clinical hold on Merck KGaA’s evobrutinib due to worries about liver injury arising from its Phase III studies in multiple sclerosis.
Merck KGaA has long held up evobrutinib as a leading candidate in the race to bring a BTK inhibitor to the MS space. Under the hold, the German drugmaker will not be able to start new patients on the drug or dose patients who have less than 70 days’ exposure to it in the US.
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