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Avanir Pharmaceuticals, Inc. Message Board

  • theefalcon theefalcon Jul 6, 2012 4:07 AM Flag

    EMA Count Down Number 1 June

    Hi all - as we are now in the final stages of the anticipated EMA approval for Nuedexta PBA I thought it would be good to track the progress each month. To get us in the swing of things I have started off with last months, the July update is due out around now as soon as it is published I will up date the thread. Please find listed below the final stages of the EMA approval process, which we can monitor and get used to while leading up to the announcement date. I would say the actual decision will be leaked prior to publication by the EMA, however we will have a good idea of what day it will be in the month, this being explained later, refer to calendar section.


    Medicines under evaluation. This is where we are at the moment. If you click on the link below you will find the latest pdf file listing the medications under review, our drug can be seen on the schedule. The notes on the pdf explains what happens after the review. For example entries are removed from the list once they have received a positive or negative review or have been withdrawn. http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/document_listing/document_listing_000349.jsp&mid=WC0b01ac05805083eb

    The next stage - Pending EC decisions (Note this is a 67 Day Process) This search allows you to find medicines that have been evaluated by the CHMP and are pending a decision by the European Commission. The Committee gives a positive or negative recommendation on whether to grant the product a Community marketing authorisation. This opinion is replaced by a full European Public Assessment Report (EPAR) once the European Commission has decided - taking the European Medicines Agency's opinion into consideration - to grant a marketing authorisation


    Pending EC decisions Link
    http://www.ema.europa.eu/ema/index.jsp?curl=pages%2Fmedicines%2Flanding%2Fsmop_search.jsp&mid=WC0b01ac058001d127&searchkwByEnter=false&alreadyLoaded=true&isNewQuery=true&status=Positive&status=Negative&applicationType=Initial+authorisation&applicationType

    European public assessment reports The European Medicines Agency publishes a full scientific assessment report called a European public assessment report (EPAR) for every medicine granted a central marketing authorisation by the European Commission. Use this search to find key information on medicines authorised for human use, including a public-friendly summary in question-and-answer format and the Package leaflet.
    http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/landing/epar_search.jsp&mid=WC0b01ac058001d125

    Events and meeting calendar, here you will find the CHMP meeting dates which will be useful in respect of what date we can expect news to be released. It does not currently publish the minutes or agendas of its meetings. It does publish highlights after each meeting.
    http://www.ema.europa.eu/ema/index.jsp?curl=pages%2Fnews_and_events%2Flanding%2Fevents_and_meetings_calendar.jsp&mid=WC0b01ac058004d5c3&isNewQuery=true&keyword=Enter+keywords&committeeSelect=CHMP&year=2012&month=7&x=18&y=10

    Meeting highlights from the Committee for Medicinal Products for Human Use Sample
    http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2012/06/news_detail_001533.jsp&mid=WC0b01ac058004d5c1

    I applogies that the above is a bit long winded, however IMO it rounds up the EMA approval process. The following monthly updates that I intend to post will be some what shorter, as those that are interested will have got used to the EMA system.

    I hope that I have been of some assistance to you all with the above. It has been a long journey getting to this stage, I must add I have been in good company. I’m convinced as I can be in respect of a positive EMA outcome.

    Very best regards to all.
    Sr Falconi

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    • Well there we have it, Congrats to all longs.

      Easy going from now on in. Given the right trial data, further indications can be added by using the efficient relatively speedy variation route.

      ALISO VIEJO, Calif., June 25, 2013 /PRNewswire/ -- Avanir Pharmaceuticals, Inc. (AVNR) today announced that the European Commission has approved NUEDEXTA® (dextromethorphan hydrobromide/quinidine sulfate) in the European Union for the treatment of pseudobulbar affect (PBA), irrespective of underlying neurologic disease or injury.

      The approval of NUEDEXTA by the European Commission is a major breakthrough for people with PBA who, until now, have had no EMA approved medications indicated to treat this debilitating disorder," said Joao Siffert, MD, chief scientific officer at Avanir. "NUEDEXTA addresses a genuine unmet patient need and demonstrates Avanir's commitment to bringing innovative treatments to people in Europe and throughout the world."
      PBA is a neurologic condition characterized by outbursts of uncontrollable crying or laughing that are often contrary or exaggerated to the patient's inner mood state. As a result, many of those afflicted with PBA show significant impairment on standard measures of health status, and disruption in occupational and social function, often leading to social isolation. PBA occurs secondary to a variety of neurologic conditions such as traumatic brain injury, multiple sclerosis, amyotrophic lateral sclerosis (Lou Gehrig's disease), Parkinson's disease, stroke and Alzheimer's disease. When these disorders damage areas of the brain that regulate normal emotional expression, they can lead to uncontrollable, disruptive episodes of crying or laughing.

      Sr Falconi

      Sentiment: Hold

    • EMA Post CHMP Positive Opinion. Update Nr 1.

      EMA/284501/2013
      Product Data Management 8 May 2013

      The information in this report was compiled on 6 May 2013.

      Applications for new human medicines under evaluation by the Committee for Medicinal Products for Human Use

      Dextromethorphan (hydrobromide)/quinidine (sulfate) remains on the list of
      of applications for new human medicines under evaluation by the Committee for Medicinal Products for Human Use. I was not expecting to see that. Go to the first web link in the first post of this thread to view the May list. You will also find stated on the first page of the May report the following.

      Entries are removed from this list once the medicine has received a positive or negative opinion from the CHMP or when the applicant has withdrawn the application.

      In respect of the above we all know that a positive broad label 30/10 and 20/10 opinion was given by the CHMP prior to the new list being compiled. Yet Dex remains on the list!

      I hope to get to the bottom of the above apparent contradiction, there must be a simple explanation. Perhaps an admin error or a misunderstanding.

      If one was inclined to joke around and hype things up a bit. One may say that a variation add on indication has already been applied for. Let’s not go rumor mongering, I shall try and seek out a substantiated reason.

      Sr Falconi

      Sentiment: Hold

    • Summary of opinion1 (initial authorisation)
      Nuedexta
      Dextromethorphan and quinidine
      On 25 April 2013, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for the medicinal product Nuedexta, 15 mg / 9 mg, 23 mg / 9 mg hard capsule intended for the treatment of pseudobulbar affect, a medical condition in which patients experience sudden and uncontrollable bouts of laughing or crying unrelated or disproportionate to their emotional state.

      The applicant for this medicinal product is Jenson Pharmaceutical Services Ltd. They may request a re-examination of any CHMP opinion, provided they notify the European Medicines Agency in writing of their intention within 15 days of receipt of the opinion.
      The active substances of Nuedexta are dextromethorphan hydrobromide and quinidine sulfate. Dextrometorphan influences the glutamate neurotransmitting pathways that regulate emotional expression, while quinidine increases dextromethorphan blood levels by inhibiting its metabolism.

      The benefits with Nuedexta are its ability to reduce the number of episodes of uncontrollable emotional expression. The most common side effects are dizziness, somnolence, headache, diarrhoea and fatigue.

      A pharmacovigilance plan for Nuedexta will be implemented as part of the marketing authorisation.

      The approved indication is: Nuedexta is indicated for the symptomatic treatment of pseudobulbar affect (PBA) in adults (see section 4.4). Efficacy has only been studied in patients with underlying Amyotrophic Lateral Sclerosis or Multiple Sclerosis (see section 5.1).
      Detailed recommendations for the use of this product will be described in the summary of product characteristics (SmPC), which will be published in the European public assessment report (EPAR) and made available in all official European Union languages after the marketing authorisation has been granted by the European Commission.

      Sentiment: Hold

    • EMA CHMP Meeting Highlights 22-25 April 2013

      Just tidying up following the positive opinion :-)

      There will be a few more posts to add in respect of the EC Decision and the reports as they are published in order to conclude the thread. Congratulations longs.

      Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 22-25 April 2013

      Overview of the opinions adopted at the April 2013 meeting of the CHMP and other important outcomes.

      Positive recommendations on new medicines.
      Erivedge Roche Registration Ltd
      MACI Genzyme Europe B.V.
      Nuedexta Jenson Pharmaceutical Services Ltd (Avanir)
      Spedra VIVUS B.V.
      Xtandi Astellas Pharma Europe B.V.

      Negative recommendations on new medicines
      Xeljanz Pfizer Ltd

      Positive recommendations on new generic medicines.
      Capecitabine Sun Sun Pharmaceutical Industries Europe B.V.
      Imatinib Accord Accord Healthcare Ltd

      Links to the EMA Web site can be found in the first post in the thread along with other useful information.

      Well done Randall and all at Avanir

      Sr Falconi

      Sentiment: Hold

    • For information and links for the news refer to the first post in the thread.


      Sr Falconi

      Sentiment: Hold

    • ICH guidelines

      IMO Some answers lie here in respect of the CHMP outcome.

      Enter ICH into the site wide search box

      According to the ICH harmonisation procedure, the following guidelines have now moved from step 4 (final document signed off by the ICH Steering Committee and adopted by the CHMP in the EU) to step 5 (regulatory implementation harmonising the technical requirements for pharmaceutical product registration in the guideline area):

      A lot of documentation to take on board.

      Sr Falconi

      Sentiment: Hold

    • EMA Count Down Number 11 April

      Product Data Management 11 April 2013

      Applications for new human medicines under evaluation by the Committee for Medicinal Products for Human Use

      EMA Web site just updated.

      Dextromethorphan (hydrobromide)/quinidine (sulfate) remains on the list. That tells me as of today Nuedexta has not been withdrawn. As the next CHMP meeting 22/04/2013 - 25/04/2013 : follows shortly hopefully that will be the last of postion one.

      Applications for new human medicines under evaluation
      by the Committee for Medicinal Products for Human Use The EMA Web page automatically updates. Use the first web link in the first post of this thread to view the April list.

      Entries are removed from this list once the medicine has received a positive or negative opinion from the CHMP or when the applicant has withdrawn the application.

      The Agency publishes information on these opinions and withdrawn applications on its website.
      Information on CHMP opinions is also published in the monthly CHMP highlights. Please refer to the other links in the first post of this thread for examples.

      Next update expected 26/04/2013

      Best regards to all.

      Sr Falconi ;-)

      Sentiment: Hold

    • EMA Count Down Number 10 March

      25th March 2013

      EMA/192989/2013
      Product Data Management

      Applications for new human medicines under evaluation by the Committee for Medicinal Products for Human Use
      March 2013

      EMA Web site just update ( later than usual). We already know the result but posting anyway in order that we have a complete record.

      Dextromethorphan (hydrobromide)/quinidine
      (sulfate) remains on the list.

      Applications for new human medicines under evaluation
      by the Committee for Medicinal Products for Human Use The EMA Web page automatically updates, use the first web link in the first post of this thread to view the January list.

      Entries are removed from this list once the medicine has received a positive or negative opinion from the CHMP or when the applicant has withdrawn the application. The Agency publishes information on these opinions and withdrawn applications on its website.
      Information on CHMP opinions is also published in the monthly CHMP highlights. Please refer to the other links in the first post of this thread for examples.

      Have a good weekend all.

      Sr Falconi

      Sentiment: Hold

    • Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 18-21 March 2013

      Overview of the opinions adopted at the March 2013 meeting of the CHMP and other important outcomes.

      Positive recommendations on new medicines as follows.
      Teriflunomide - Sanofi
      Human normal immunoglobulin - Baxter Innovations GmbH
      Ponatinib - Ariad
      elvitegravir / cobicistat / emtricitabine / tenofovir disoproxil - Gilead
      dimethyl fumarate - Biogen

      Negative recommendations on new medicines
      Defibrotide - Gentium SpA
      budesonide / salmeterol - SMB S.A

      Positive recommendations on new generic medicines as follows.
      memantine hydrochloride - ratiopharm
      bosentan monohydrate - Marklas
      voriconazole - Accord

      Re-examination of recommendation for new medicine
      Mipomersen – Genzyme

      Withdrawal of application
      iloperidone – Fanaptum
      autologous oral mucosal epithelial cells - OraNera

      Links to the EMA Web site can be found in the first post in the thread along with other useful information.

      Next CHMP Meeting dates 18/04/2013 - 21/04/2013

      Very best regards to all true longs.

      Sr Falconi

      Sentiment: Hold

    • One Two Testing Testing

      The first post in the thread may also be useful to those that would like to know the EMA system procedures and see the next highlights from the CHMP meeting, just follow the links.

      Sr Falconi ;-)

      Sentiment: Hold

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