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Multiple sclerosis: Could Roche’s bestselling drug Ocrevus be doing more harm than good in women with primary progressive MS?
BMJ 2026; 393 doi: https://doi.org/10.1136/bmj.s666 (15 April 2026) Cite this as: BMJ 2026;393:s666
Neurological drugs have been in the media over the last couple of days. There is a report that Alzheimer drugs are not good enough and it has been funny that people at the same place as where the idea arose question the impact of targeting the amyloid hypothesis. After failed study after failed study the FDA approved the use of agents despite people on their panel questioning the benefit. NICE says the benefit is not cost effective. I have always wondered about the merit of using antibodies to treat CNS disease as they are 99.9percent excluded from the CNS There was a thought that the FDA were keeping pharma sweet to stop them walking away from Alzheimer research.
So it seems that the person at the FDA approving the Alzheimer drugs also approved ocrelizumab for all of primary progressive MS. The media are questioning the value in females as it has also been reported that there was more breast cancer in the trials.
The thing I would like to say is that in Europe they never bought the efficacy like the FDA did. Ocrelizumab does not have blanket approval They saw that the trials were loaded with potential responders based on earlier failed rituximab trials.They approved ocrelizumab for progressive MS with active lesions which is the biology targeted in relapsing MS. This has a clearish biology and you get rid of B cells before they get in the CNS. There are 4 anti-CD20 in use in MS for relapsing MS and they work to limit disease activity in both sexes. Antibody doesn’t need to get into the CNS. People with PPMS have lesions and this element should respond to anti CD20 The impacts of targeting non active progressive disease is mute and tolebrutinib is reported to have an affect but it is not great. This needs a different treatment in my mind as it is a different biology. The O hand trials support activity of ocrelizumab in progressive MS trials. However there will be a limit to the benefit because addition biology needs to be targeted.
Now the question is whether the cost benefit is sufficient and that boils down to the regulators. In the trials there were more cases of breast cancer in the drug arm. I believe real world monitoring has not relocated this but it should not be hard to replicate this there are loads of women on anti CD20.now. Likewise I don’t think that this cancer signal appeared in the O hand study. The FDA labeled cladribine with problem in trials there was more cancer on drug the odd thing was actually there was no cancer in the placebo arm, yet the cancer mud has stuck and the other problem was the loss of lymphocytes.. it’s the mechanism of action if the drugs don’t deplete they are not working well. I do not think there was a breast cancer signal in other anti CD20 trials.
The FDA are apparently reviewing the data it shouldn’t be difficult. Roche gives access to the whole trial data set they can work it out themselves. I had access to full data set of Opera studies.
However is there a realisation that by throwing a bone to pharma to approve a drug that is not that effective they make it harder for new drugs to arrive. With ocrelizumab in place it means that trials should do head to head….. at 1000 people in the comparator arm at 200,000 dollar a person for two year study cost 200 million. They then need to recoup the cost and drugs are expensive.
Frexalimab is in trial in progressive MS another antibody in the mix for progressive MS. Will we ever learn? If the FDA unapproved ocrelizumab will other companies be happy about clearing the competitor away. Now that’s a conspiracy theory..
In response to the question I think the answer will be unlikely but fundamentally I think we need combination therapy to deal with the biology of MS. I wonder when the ocrelizumab patent ends….if the approval ends there are no cheap biosimilars arriving.
Coi multiple
Disclaimers. I am sure the great and the good will have something to say.
There has been
Source: multiple-sclerosis-research.org