Another Case of PML on Tecfidera/Dimethyl Fumarate without too much Lymphopaenia this time

#MSResearch #MS. Another case of #PML on #Tecfidera #Fumarate

Someone or some people have been criticizing TeamG over what be say, but maybe this person needs to start eating some of their words.

I just posted on the effect of lymphopaenia after DMF and commented on how ProfG disagreed with the EMA advice that a lymphopaenia level of 500 cells per microlitre was OK, when PML had occurred in psoriasis when lymphopaenia had occurred when cell numbers were persistently lower than 800 cell per microlitre.

We then had a spy post two days ago to say that the fourth person with PML and tecfidera had occurred and despite many requests to verify the source nothing was there on the web, so I removed it.

However despite nothing appearing on the Biogen website (why not) sure enough it appears that the fourth case of PML with tecfidera has occurred.

Biogen has apparently reported a fourth case of PML with Tecfidera -- this one in a patient with only moderate lymphopaenia -- to U.S. and European regulators, raising new questions about the drug's safety.

According to Medpage (why is this not easily found on the Biogen website?). The latest case occurred in a 61-year-old female with relapsing-remitting multiple sclerosis, who'd been taking Tecfidera for 22 months before being diagnosed with PML.

She had grade 2 lymphopenia, at 600 cells/mm3, for 6 months before developing symptoms of PML, which included left arm weakness and apraxia. So this comment on Grade 3 lymphopaenia being a limit by ProfG is vindicated it seems.

This is sad news for the person affected and you need to assimilate this if you are a healthcare professional as the EMA guideline needs a rethink.

Apparently Biogen stock has been down-graded recently by Zacks credit rating and it was suggested that if another case of PML occurred it would be bad news..so this bad news may now occur and it is interesting that quite a bit of stock has been flogged in the last day or so...so no chance of insider dealing then?:-)

ProfG is away at present and may say more.

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