Monday, 23 January 2012

Fingolimod deaths and the EMA

Anxious? If you are on fingolimod (Gilenya) and have any queries please read the European Medicines Agency's press release, their Q&A paper or leave a comment on the blog which we will respond to.

10 comments:

  1. I have some questions:

    * Has there been any indication of how old the people who died from taking fingolimod were? Is there any proof that as young people with MS we may have a better experience with such drugs as opposed to older MS'ers? Is there an age factor involved with the risks of taking potent drugs like fingolimod?


    * NICE is already on the fence when it comes to fingolimod. I take it this news won't help the situation? Furthermore, will the pharma be more inclined to now reduce the cost of fingolimod as means of boosting sales in the light of falling share price?

    * What are Novatis' responsibilities now? What does it need to do? Is there a chance they may pull the plug on fingolimod? In that case what happens to those who are doing well on the drug? It seems wrong to now deprive them.

    * How can one reduce the risk of such severe side effects? How can MS drugs be made to provide safer treatment? Are the drugs you are currently researching for progressive MS safer optins than say fingolimod?

    * Why is fingolimod not spelt with a capital 'F'?

    Thanks in advance for answering my questions.

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  2. I have been on Gilenya since March 2011. Besides reporting side effects, are there recommendations for me? Should I seek out a cardiologist to do another EKG?

    During the first 6 hours of taking 1st dose you are supposed to me monitored. I know I was checked every hour for pulse and blood pressure.

    of the 11 deaths were they all after the first dose or were some further along. I have a call into Novartis to discuss all of this as well.

    Are they looking at "healthy" subjects to see if any CardioVasular issues are occuring?

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  3. Re: "I have some questions"

    These are difficult ones and I will forward your comment to someone in medical affairs at Novartis to answer. It is the convention tend to spell generic names (fingolimod) with small letter and to use capitals for trade names (Gilenya).

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  4. Re: " have been on Gilenya since March 2011. Besides reporting side effects, are there recommendations for me? Should I seek out a cardiologist to do another EKG?”

    If you have no symptoms or cardiovascular risk factors (smoking, hypertension, diabetes, high cholesterol) I would say no. However, this advice may change if evidence emerges to show that fingo causes delayed conduction problems.

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  5. Re: “During the first 6 hours of taking 1st dose you are supposed to me monitored. I know I was checked every hour for pulse and blood pressure.”

    That was fine back then; the EMA now recommends continuous monitoring during the initial 6 hour period.

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  6. Re “Of the 11 deaths were they all after the first dose or were some further along. I have a call into Novartis to discuss all of this as well. “

    I don’t know the details of the cases; but will update you when the info becomes available.

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  7. Re: “Are they looking at "healthy" subjects to see if any Cardiovascular issues are occurring?”

    This has been done already as part of the phase 1 studies that have to be done for all new drugs. Phase 1 studies are typically done in young health men.

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  8. Prof. G what are the risks of dying on other MS therapies; are they as high as Fingolimod?

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  9. Re: "Prof. G what are the risks of dying on other MS therapies; are they as high as Fingolimod?"

    A very pertinent question and difficult to answer. In relation to Copaxone and interferon beta the risks are low; but I don't have the figures at hand. For Natalizumab the risks are higher and mainly relate to the 20% mortality rate in those who get PML. The EMA press release suggests there have been several unexplained deaths on fingolimod.

    Unfortunately, without a proper denominator (number of treated subjects) corrected for time (patient years) it is difficult to make comparisons. In addition, you have to factor in the risk:benefit ratios when comparing agents.

    As data enters the public domain I will endeavour to provide it to you in context.

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  10. Just a comment relating to Phase 1 studies being conducted in healthy young males. In light of the sex ratio for this disease - this is cause to query the validity of the testing pool. Girly hormones are mystical and do quite different things. Not seeing any boys in the estriol and MS trials. A comment please on the oestrogen effects in MS and on the estriol studies.

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