How do you like your DMT served, long and slow or quick and easy?
The regulators have the trial data for ofatumumab and it will now be up to the regulators to see how quick they approve the drug. It looks like the Americans will win with a Summer 2020 showing and the EMA will lag behind for 2021. In future what will the MHRA (UK regulators) do…follow the EMA or the FDA. Recently the FDA has been splurging when it comes to breath of approvals. Siponimod and cladribine got CIS to SPMS so why not this for ofatumumab? If anti-CD20 is approved for PPMS and RRMS will ofatumumab be give the green light for all. This could be ground breaking. Pharma would then on have to do two trials for MS not 6 or more for the different bits of MS. MS would be one disease. Will the EMA be narrow and approve for “active MS”..I bet this happens, too many neurosaurs (dinosaur neurologists) in Europe.
How will the battle lines be drawn up? 6 monthly dosing, verses monthly dosing. One potential advantage is that if things go wrong, you can stop with the subcutaneous dosing, and you have the mental comfort of recieving regular treatment and no visits to he hosptial, but how good is the dosing? Is it enough, given that Roche are claiming that the more drug on board the better the effect on progression? Dr Angry will be making an anti-drug test…may he has done it already, as it is matter of time before some people develop allergies to it after all it is delivered by a sensitizing route….Don’t kid yourself that because it is human that ADA won’t be an issue for some people, although by dosing every month that may stop this issue. I’ll wait and see.
Now the data I want to see is how quickly do the cells return after injection. Once approved we will never know as the B cells will be hammered forever. I know the immature cells come back as do the CD19 B cells, but we all know boys and girls that this is not what we should be looking at. It is how quickly those memory B cells repopulate and if they don’t, which will eventually happen, then you may not need as much as monthly dosing. Funny I had a quick look on the ECTRIMS site and the memory B cell data isn’t shown I wonder why?. I bet we can guess what happens…freedom of information request time. Maybe I just missed it.
Work from Italy (ECTRIMS 2019) with rituximab is showing that you can dose to when memory B cells return and maintain remission with fewer doses, just like in a number of other conditions.