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Clinical Hold For Merck KGaA’s BTK Inhibitor Evobrutinib For MS Raises Class Safety Fears

Third To Be Hit With MS Clinical Hold

 
• By Ayisha Sharma

Adding to a growing pattern within the BTK inhibitor pipeline for multiple sclerosis, the US FDA has placed Merck’s evobrutinib on a partial clinical hold following two liver injury incidents, prompting questions over its ultimate approvability.  

Stop sign
The Hold Means New Patients Cannot Be Treated With Evobrutinib • Source: Shutterstock

Merck KGaA’s Phase III Bruton's tyrosine kinase (BTK) inhibitor asset evobrutinib for multiple sclerosis (MS) has been put on partial clinical hold by the US Food and Drug Administration after liver events, increasing concerns over a possible class safety effect.

The decision came after two patients in Phase III studies of evobrutinib saw lab values indicating drug-induced liver injury

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