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

On Germany's Merck KGaA's (OTC:) plans to start treating new patients, the FDA has temporarily placed a clinical hold. MKGAF) (OTC: The Phase 3 EVOLUTION trial program of ibrutinib in relapsing multiple sclerosis (RMS) will continue as planned, with all participants remaining on treatment as they are beyond 70 days of exposure to study medication. MKKGY) ibrutinib and patients with less than 70 days of exposure to study medication in the United States

Even though the two cases identified were asymptomatic and the patient's liver enzymes had fully normalized after discontinuing the study medication, the decision was made in response to laboratory values that suggested drug-induced liver injury during phase 3 studies.

In a statement, the company stated, "Merck is working closely with the FDA to establish the excellent route ahead for the advantage of sufferers in contemporary and destiny trials with ibrutinib.

Only two patients are impacted by the FDA's decision. According to Reuters, recruitment for a phase 3 drug trial with 2,000 participants has already been completed, and an ongoing study will proceed as planned.

Evobrutinib's Phase 3 trial program is expected to conclude in the fourth quarter of 2023.

Price Change: Shares fell 6.3% to €162.45 on the European stock exchange.

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The original publication on Benzinga.com was FDA Issues Partial Clinical Hold on Merck Germany's Multiple Sclerosis Study.