Sunday, 1 June 2014

EMA says no to Laquinimod

Should we have done more to speed up laquinimod development for progressive MS? #MSBlog #MSResearch

"Apologies for not posting the news below earlier; it is now old news. It is the press release from TEVA and a Q&As letter from the European Medicine Agency announcing a refusal of a marketing authorisation for laquinimod. This is great pity as it means laquinimod development will progress slower than it should. As you aware laquinimod appears to have neuroprotective effects downstream of focal inflammatory events in MS. Despite it only being mildly effective at suppressing relapses and focal MRI activity laquinimod reduces the rate of disease progression and brain atrophy in MSers. I have made the case for it be used as the ideal add-on drug in MS in the past. The problem with laquinimod not getting a European license is  that it makes it difficult to do combination therapy studies with laquinimod. Regulators like to only test one unknown at at time in clinical trials, Hence doing add-on studies with two unlicensed drugs is very difficult. If laquinimod had been given a license investigator's could then have started doing innovative add-on studies to see if a combination of two drugs can help address the unmet need, and disease burden, of progressive MS. For example, it would be interesting to see if potent anti-inflammatory drugs, such as alemtuzumab and rituximab, when combined with laquinimod can slow the rate of progression in SP and PP MSers. Now that the drug has not been licensed we can't do these studies; we have to rely on TEVA doing these studies. This is when MSer activism may have helped the cause! Do you think a few thousand MSers in wheelchairs, scientists and clinicians protesting outside the EMA would have changed their opinion? MSers are all crying out for a treatments for progressive MS and we let this one get delayed by 5 or so years. The only good news is that TEVA have not abandoned ship and are still working on the drug for both relapsing and progressive MS. It simply means things will take longer for progressive MS and another generation of MSers with relapsing MS may slide down the hill."





CoI: multiple

6 comments:

  1. as a patient with PPMS could you please explain how laquinimod would treat the cause of my MS and how does my immune system malfunction differently from RRMS and SPMS?

    many thanks

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    1. RRMS is driven by the immune system entering the cns and is probably t and b cell driven it seems that laquinimod is pretty rubbish at dealing with this.

      However it appears that it could be a neuroprotector possibly because it is a microglia inhibitor, it inhibits a molecule called nuclear factor kappa B which is important in glial activation so it could be useful in PPMS and SPMS and as an add on in RRMS.

      However it is time to find a cheap DMT so they can charge more for neuroprotectives or are the neuroprotectives going to be cheap or can you afford two expensive drugs. I gueess if you have the money

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    2. so are you saying that if I am primary progressive my immune system behaves differently from the outset of my disease? how do the T and B cells behave differently in PPMS, SPMS, CIS, RRMS? are they more or less aggressive? in which case all the drugs should work across all the different diagnoses of MS and be dose dependent? apologies if my questions are on the dim side

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    3. CIS RRMS and relapsing ppms respond to current DMT.
      A different type of DMT appears to be needed for progressive MS. In animals T cells set off the progression thiz cN occur from onset or after relapsing remitting disease.

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  2. I've posted this before but is the parliamentary all-party MS committee up to speed on this and similar issues? And if not, why not? Wouldn't it be more effective to lobby members of this group than MPs in general?

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    Replies
    1. About as fast as a snail i suspect. what has this committee ever done?

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