FDA Issues Partial Clinical Hold On Merck Germany's Multiple Sclerosis Study

Author: Vandana Singh | April 12, 2023 10:12am

• The FDA has placed a partial clinical hold on initiating new patients on Germany's Merck KGaA's (OTC:MKGAF) (OTC:MKKGY) evobrutinib and patients with less than 70 days of exposure to study medication in the U.S. 
• The ongoing Phase 3 EVOLUTION trial program of evobrutinib in relapsing multiple sclerosis (RMS) will continue as planned, with all participants remaining on treatment as all are beyond 70 days of exposure to study medication.
• The decision was in response to laboratory values suggestive of drug-induced liver injury during phase 3 studies, stressing that the two cases identified had been asymptomatic and the patient's liver enzymes had fully normalized after discontinuing the study medication.
• "Merck is working closely with the FDA to establish the best path forward for the benefit of patients in current and future trials with evobrutinib," the company said in a statement.
• The FDA's decision impacts just two patients. Reuters reported that recruitment for a phase 3 drug trial was already complete with 2,000 participants, and an ongoing study will continue as planned.
• The Phase 3 trial program of evobrutinib is on track to read out in Q4 of 2023.
• Price Action: On the European stock exchange, shares plunged 6.3% to €162.45.

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