Monday, 25 April 2011

BG12 phase 3 data

Twice-daily BG-12 significantly reduced the proportion of patients who relapsed at two years by 49% vs. placebo (p<0.0001). On secondary endpoints, BG-12 significantly reduced annualized relapse rate (ARR) and disability progression by 53% and 38%, respectively, vs. placebo at two years. Mode of action: BG12 or dimethyl fumarate activates the NF-E2-related factor 2 (Nrf2) pathway; this pathway is both anti-inflammatory and neuroprotective.

BioCentury Press Release

"Unexpected results for a drug that is not immunosuppressive. The good news is that BG12 comes with a large pedigree of safety from its use in psoriasis. If these results are confirmed this drug is a paradigm changer and will almost certainly have positive effects in a large number of other, neurological and non-neurological, disorders."

COI: I am a member of the phase 3 clinical trial steering committee.

7 comments:

  1. How much does it cost now for use in psoriasis? How much is likely to cost when finally approved for MS?
    Is there any chance of it being priced at a level that doesn't cripple the payer?

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  2. can we get on the trial? or is it too late? Are there any further details we can read, sounds very interesting.

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  3. The phase 3 trials are fully recruited! However, I suspect there will be additional studies, including add-on studies.

    The version of the drug for psoriasis is called Fumaderm and is available in Germany. It is not exactly the same as BG12, which is an improved version and is associated with better tolerance.

    As for the price; I have no idea. Pharmaceutical drug pricing is a dark art! However, the age of cheap drugs are gone. The costs of developing new drugs is so high and the regulatory requirements so arduous that all new drugs will be "relatively" expensive.

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  4. When will it be available to the public?

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  5. The second phase trial has to finish, the data analysed and then the results submitted to the FDA and EMA (American and European Regulatory Authorities). Realistically, BG12 will only be available in the second half of 2012 and in some markets, for example the UK, in 2013. The delay in the UK relates to the additional cost-effectiveness assessment needs to done by NICE (the National Institute of Clinical Excellence).

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  6. Im in Canada...so I imagine it will be a while before it is available here then.

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  7. In general new MS DMTs are typically available in the US first and followed 6 to 12 months later in Europe, Canada and Australia. Access via the NHS is typically 12 months behind that so I suspect it will be available to you in Canada before the UK.

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