The US regulator has placed oral BTK inhibitor orelabrutinib on partial clinical hold, meaning new patients cannot be enrolled into clinical trials and patients treated with the drug for 70 days or less must discontinue treatment.
Those already taking orelabrutinib for 70 days or more can however continue receiving the drug, which is in a phase 2 trial in relapsing-remitting multiple sclerosis (RRMS) as well as early-stage studies in other autoimmune diseases. InnoCare says it will also introduce the restrictions on studies ongoing outside the US.
