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   DIR Return to: TECFIDERA (dimethyl fumarate, BG-12, Fumaderm)
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       #Post#: 866--------------------------------------------------
       Biogen reports 2nd Tecfidera PML case
       By: agate Date: July 18, 2015, 5:54 pm
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       From MedPage Today, July 16, 2015:
       [quote]Biogen Reports Another Tecfidera PML Case
       Non-fatal case is the second one for the oral MS drug.
       by Kristina Fiore
       Staff Writer, MedPage Today
       There's been a second case of progressive multifocal
       leukoencephalopathy (PML) with dimethyl fumarate (Tecfidera) for
       multiple sclerosis, a Biogen spokesperson confirmed.
       The company said it reported the case -- which wasn't fatal --
       to regulators including the FDA but would not specify where the
       case occurred.
       It occurred in a patient with primary progressive MS who had
       prolonged severe lymphopenia, which is on the drug's label as a
       risk factor for PML, according to Biogen spokesperson Catherine
       Falcetti.
       "It's very similar to what we saw with the other case," Falcetti
       told MedPage Today. "It's within the risk profile, and the
       risk-benefit ratio remains favorable."
       The other PML case with Tecfidera, reported in the New England
       Journal of Medicine earlier this year, occurred in a 54-year-old
       woman with MS, who had severe lymphopenia for 3.5 years.
       Another case of PML was reported at that time, but it occurred
       in a patient who was taking a compounded formulation of dimethyl
       fumarate for psoriasis.
       Biogen had also reported cases of PML with its branded oral
       dimethyl fumarate product Fumaderm, which is available on the
       European market as a treatment for psoriasis.
       Tecfidera has been available on the U.S. market as a treatment
       for MS since 2013. Falcetti said the company does not anticipate
       any changes to the drug's label at this time, and she urged
       physicians not to change their practice with the drug but to be
       vigilant about prolonged severe lymphopenia as the label
       indicates.
       Biogen is very experienced with PML -- it's the firm that
       introduced natalizumab (Tysabri) in 2004, only to discover a few
       months later that the drug raised the risk of PML in patients
       with latent JC virus infection.[/quote]
       This article can be seen here
  HTML http://www.medpagetoday.com/Neurology/MultipleSclerosis/52622?xid=nl_mpt_DHE_2015-07-17&eun=g345846d0r.
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