Tuesday, 28 June 2016

NewsSpeak: ocrelizumab applications accepted by the FDA and EMA

At last the clock starts ticking for the long ocrelizumab wait #NewsSpeak #Ocrelizumab #MSBlog

"You may have heard already that Roche have finally submitted their RRMS and PPMS dossiers in relation to ocrelizumab to the FDA and EMA (see today's press release below). Ocrelizumab illustrates how long the drug development process takes.  The PPMS ocrelizumab results were made public last year at ECTRIMS and the dossier has only just been submitted approximately 9 months later. The FDA has fast-tracked ocrelizumab so PPMSers in the US should get an answer within 6 months. In Europe the EMA will take up to 12 months and then NICE will have to look at its cos-effectiveness, which typically takes 6-12 months and then post-NICE there is a 3 month delay before NHS England allows us to use it. So in the UK anyone with PPMS hoping to be started on ocrelizumab may have to wait another 2 years, that is assuming is clears all the regulatory and access hurdles. The red tape is unbelievable and then you ask us why academics don't develop drugs?"


CoI: multiple

20 comments:

  1. Thank goodness we Brexited. Now we can expedite medicines for ourselves.

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    1. Not so sure...we have no idea what is in store, will the EMA be moved from London?

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    2. Really? I think that is extremely unlikely.

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    3. Brexit is not going to reduce medication approval times. There is not even a government body to do the approval. If we cannot still use EMA then it will take years to build the relevant authority in the UK. Approving medications will probably be a lower priority than all the other government departments and institutions that need to be rebuilt. Going to be a hard 10 to 15 years.

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    4. i got the feeling the original comment was dripping with sarcasm lol

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    5. yep probably, but there are many open nerves at the moment

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  2. So is this application to use ocrelizumab specifically for PPMS or all types of MS? I thought an application for its use in RRMS was already underway?

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  3. Why wasn't SPMS included in the study (if you know)?

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    1. Re: "Why wasn't SPMS included in the study (if you know)?"

      SPMS was not included. However, a proportion of MSers in the trial will have SPMS already (progression without relapses) so post-hoc analysis of the data will allow us to drill down and look at the impact of ocrelizumab on this subset of MSers.

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  4. Oh dear, this is such a long wait for a drug that will be made available in the end. What a waste of time, bit like the ridiculous wait we had for DMF. I don't know the difference between alemtuzamab, daclizumab and ocrelizumab and if there will be a shakedown of which drug will be preferred but I am a bit scared about having alemtuzumab but it is too long to wait for the others.

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    1. Yes...unfortunately all MSers are good at waiting. As the song goes "The waiting is the hardest part"

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    2. Efficacy wise alemtuzumab and ocrelizumab are about the same
      More active than daclizumab I think on relapse rate.

      Side effect wise ocrelizumab lacks autoimmunity issues of alemtuzumab and daclizumab
      but infection wise ocrelizumab has issues

      Alemtuzumab 8 days treatment maybe forever or a long time for 40% of people, ocrelizumab every six months ,but could it be induction too, and both an infusion whereas daclizumab is once a month injected in the skin.

      Alemtuzumab here and now in UK and to some extent the US but you have a 1 to 2 year wait in the UK for the other two daclizumab will arrive first as it ahead of the game.

      All active and all have issues.

      Until we know the prices it is hard to know how NICE will work but rest assured it will be maximised for the cost.

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    3. Efficacy wise alemtuzumab and ocrelizumab are about the same
      More active than daclizumab I think on relapse rate.

      Side effect wise ocrelizumab lacks autoimmunity issues of alemtuzumab and daclizumab
      but infection wise ocrelizumab has issues

      Alemtuzumab 8 days treatment maybe forever or a long time for 40% of people, ocrelizumab every six months ,but could it be induction too, and both an infusion whereas daclizumab is once a month injected in the skin.

      Alemtuzumab here and now in UK and to some extent the US but you have a 1 to 2 year wait in the UK for the other two daclizumab will arrive first as it ahead of the game.

      All active and all have issues.

      Until we know the prices it is hard to know how NICE will work but rest assured it will be maximised for the cost.

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    4. lol in Australia neuros and societies are quoting 1 year to ocrelizumab. australian PBS meets 4 times a year. No application for use has yet been made in Australia to the TGA from what I understand (though there was a claim by the company some time ago that contemporaneous worldwide applications would be made). To me it all sounds a bit like gambling.

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  5. You are saying all the MS antibodies are effective but have issues so in the end how do you weight the risk- benefits of these new antibodies if they are all more or less equally effective? …..However, looking at the warning box coming with daclizumab and the 3rd line indication it got in USA I have the feeling that ocrelizumab is probably safer then daclizumab . Looking at daclizumab’s safety data it didn’t look so dangerous…. Is this because Americans are more risk averse?

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  6. Any thoughts about ocrelizumab ‘s safety issues like cancer risk? Will it be enough to recommend monitoring as for the monthly blood tests required to check the risks on PML or liver function? Is this sustainable in the long run ?

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    1. Any chance of a name/pseudonym rather than anonymous? It helps and makes it more likely your query is answered in a timely manner.
      Sorry to keep banging on about this everyone.

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  7. sure, you are right, the last 2 posts are from Lele

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