Blogging with Parkinson's

A personal perspective on Young Onset Parkinson's

Doubts over Rasagiline’s Ability to Slow Progression of Parkinson’s

2 Comments

An article on the Forbes Web site reports that the US FDA (Food and Drug Administration) have refused an extended licence to Teva, manufacturers of Azilect, the drug also known, generically, as rasagiline. Teva (not to be confused with the footwear manufacturer) were seeking to licence rasagiline for its mooted protective properties. However, these have not – as my own consultant pointed out to me, the last time that I saw him – been satisfactorily proved.

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2 thoughts on “Doubts over Rasagiline’s Ability to Slow Progression of Parkinson’s

  1. The FDA’s line was basically that they couldn’t officially approve the drug for the purpose of “disease-modification” (the officially preferred term over “neuroprotection”) because the results are ambiguous. Even knowing that the proof for the possibility of disease-modification was absent, my consultant(s) were still happy for me to take the drug – and to continue taking it after starting different medication; their reasons seemed to include, “well, it might be a little bit neuroprotective”. I doubt that a decision made by an American body will sway them. Rasagiline is considered to be low risk: “almost a vitamin”, as the senior consultant in Southampton said. (Obviously, this is apart from the hair-falling-out thing, which, as it happens, seems to have stopped happening to me. I think it was a magnified summer moult or something. I’ve still got more than my fair share of hair!).

    I’d be interested to know which way the cited gender imbalance was leaning.

    I found this:
    http://www.pdonlineresearch.org/responses/21919/123/rasagiline-and-adagio-trial-results-what-now
    which is a measured response to the report that rasagiline probably isn’t disease-modifying (the officially preferred term over “neuroprotective”).

    I also found two of the papers reporting the study in which the ambiguous results were found:
    http://parkinsoninfo.parkinsonforbundet.se/wp-content/uploads/rasagiline-adagio-olanow-2008.pdf
    http://static.vademecum.es/documentos/evidencia/Azilect/ADAGIO%20on%20line%20NEJM2009.pdf

    The full papers are located at the above addresses. Given that I’ve only just found them, and have only skimmed through, I haven’t managed to answer my own gender query yet, although I did note that the mean age of the subjects was 60ish, with the youngest being 31 (so there were a few Young Onset PWPs in the study) and the oldest in their 80s.

  2. This seems to be a hot topic, even outside of America.

    Jon Stamford of the Parkinson’s Movement reports on the subject:
    http://www.parkinsonsmovement.com/2011/10/17/rasagiline-neuroprotective-or-not/

    From the US comes a press release from the PDF (the Parkinson’s Disease Foundation, which has nothing to do with Adobe’s Portable Document Format, although they do issue PDF documents on occasion):
    http://www.pdf.org/en/science_news/release/pr_1318886597

    In fact, here is a PDF from the PDF (referred to in the above press release):
    http://www.pdf.org/pdf/parkinson_community_azilect_101711.pdf

    This latter refers to a continuation of Teva’s ADIAGO study, due to be completed in 2013. Obviously I, like many others, would like rasagiline to be disease-modifying, but more than that I want the science to be done thoroughly and for it to be reported honestly. So far, Teva ‘s researchers seem to be doing a grand job; their very paper urges caution on the interpretation of the neuroprotectiveness of the drug. The fact that the parent company requested an expanded license on the basis of flimsy evidence speaks only of the marketing department’s eye for a chance. If nothing else, I would imagine that the current discussion of the FDA’s decision is still a plus for Teva’s marketeers – awareness is half of the battle in selling, and this story will make doctors and patients around the world consider Azilect.

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