Fenebrutinib Update. Clinical Trial Results, Liver Disease, and Death

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“this is a difficult disease to treat. We don't have many options. If we can reduce progression somewhat and there are no major side effects, certainly that would be worthwhile. Also the reality is that the use of drugs has different effects in different people. There could be some individuals where the drug is completely ineffective and in other people they just seem to respond to the drug and are perfectly stable and have no progression. And maybe we could figure that out with individual use. Of course the concern is the risk of side effects, the risk of elevation of liver enzymes and of course the potential increased risk of deaths. and the rate of deaths was numerically low but still greater than what has previously been reported with other randomized trials. For instance, in the ortorio trial, the rate of deaths was significantly lower. Now, I personally would not recommend this drug to people with relapsing MS, especially people who are young and healthy and doing well on other disease modifying therapies. I certainly wouldn't recommend it to someone who is newly diagnosed or has never taken a disease modifying therapy. For progressive MS, people who have tried other agents and still progressed, including the B cell depletters, I have mixed feelings. I'm definitely concerned about the risk of liver injury and potentially the increased risk of death. I'm not sure if the FDA will actually approve this drug. I'd like to know your thoughts. Do you think the FDA should approve it?”