|
|
|
|
||
EuropeAa I have been trying to track what is going on in Europe, regarding pimavanserin and any evidence of movement regarding the MAA. Well, after a lot of head scratching, I think I may have found something. Let's look at what information is out there: 1. The PDCO decision regarding the PIP. Take a look at the google search below, and open the second link, which refers to EMEA-001688-PIP03-16. https://www.ema.europa.eu/en/search/search?search_api_views_fulltext=Emea-001688-pip03-16 When you open that up, you will find the EMA recommendation, regarding the waiver and the reference to pimavanserin as a potential treatment for 'SCHIZOPHRENIA AND OTHER PSYCHOTIC DISORDERS'. 2. If you then google search 'pimavanserin 2019' on the EMA site, you get the following result: https://www.ema.europa.eu/en/search/search?search_api_views_fulltext=Pimavanserin 2019 3. The third item on that search result list looks interesting doesn't it: List item PDCO: Agendas, minutes and meeting reports Of procedure 03 January 2019 for Nomination of Rapporteur … Trouble is, if you go through the meeting agenda, minutes and reports for PDCO meetings in pimavanserin for the whole of 2018, you find no reference to pimavanserin. So, having scratched my head more than a little, I tried the following, a Google search of 'EMA of procedure 03 January 2019 for Nomination of Rapporteur'. That yielded the following. 4. https://www.google.com/search?q=ema+Of+procedure+03+January+2019+for+Nomination+of+Rapporteur'.&oq=ema+Of +procedure+03+January+2019+for+Nomination+of+Rapporteur'.&aqs=chrome..69i57.9992j0j8&client=tablet-android-samsung&sourceid=chrome-mobile&ie=UTF-8 Now, look at the second item in the list, the reference to the October 2018, PDCO meeting. Open up that document, and look for pimavanserin, you will not find anything, BUT if you look for a reference to 3rd January, you will find the following: List of letters of intent received for submission of applications with start of procedure 03 January 2019 for Nomination of Rapporteur and Peer reviewer ...................... 32 32 is the page reference in the document index, so if you then look at page 32, amongst other things, you will find: Disclosure of information related to this section cannot be released at the present time as it is deemed to contain commercially confidential information. 4.1. List of letters of intent received for submission of applications with start of procedure 03 January 2019 for Nomination of Rapporteur and Peer reviewer Action: For adoption 5. So, then I referenced the EMA CHMP process, for the centralised approval of new drugs, just to be clear as to where the company might be in that process right now. The google search I used was: ema appointment of rapporteur Now, in the subsequent search result list, the second entry should be titled 3143 SOP. Open it up, and take a look it is the EMA SOP that deals with the appointment of the rapporteurs. https://www.google.com/url?sa=t&source=web&rct=j&url=https://www.ema.europa.eu/documents/sop/standard-opera ting-procedure-chmp/cat/prac-rapporteur/co-rapporteur/peer-reviewer-appointment-centralised-procedur e_en.pdf&ved=2ahUKEwjo2bH-pvLfAhUkRhUIHUvlCXgQFjABegQIBRAB&usg=AOvVaw06gDL_Mg63Bx-JUHXxEM0U What else do we know? Well, we do know ,that a paediatric trial is about to start in Europe for pimavanserin, as evidence by this entry on the central database: Look at the second entry from the top: https://www.clinicaltrialsregister.eu/ctr-search/search?query=Pimavanserin We also know by mid year, that the company will have a wealth of data to support an MAA application in Europe, REMEMBERING that pimavanserin is registered as potential treatment for 'SCHIZOPHRENIA AND OTHER PSYCHOTIC DISORDERS', such as (not saying this is the complete list, and some might argue about relevance of some, given the label Acadia are angling for). 1. The 008 phase 2 schizophrenia trial that took place some years ago. 2. The 042 MDD trial results. 3. The 019 Alzheimers trial results. 4. The 020 PDP trial results. 5. The 048 trial for Parkinson’s Disease and Depression. 6. The 034 Schizophrenia trial. 7. The 038 Schizophrenia trial. 8. The 032 Alzheimers and Agitation trial. 9. The 033 Alzheimers 52 week extension trial - more on this one in a minute. Where are we in the process? It seems right at the beginning, which is consistent with what we can glean from the EMA site (big assumption here, that the confidential information references in the PDCO documents do relate in part at least to pimavanserin, but timescales feel about right). This is a handy overview of the process: https://www.google.com/url?sa=t&source=web&rct=j&url=http://www.ema.europa.eu/docs/en_GB/document_library/P resentation/2009/10/WC500004235.pdf&ved=2ahUKEwjUn8iGsPLfAhV1RxUIHfbdBPoQFjAAegQIBBAB&usg=AOvVaw1px9RXcxwHB-L-L0Rq8e0g&cshid=1547644333144 The Alzheimers Extension Trial The 033 trial stopped recruiting somewhere between the 13th and 26th February, 2018, according to the clinical trials archive. https://clinicaltrials.gov/ct2/history/NCT03118947?A=3&B=4&C=Side-by-Side#StudyPageTop The Clarity MDD trial trial finished recruiting on or before 27th July 2018, and the results were published on the 31st October 2018. Assuming a similar time lag before results are reported for the 033 extension trial, then they will be known around the end of May. So, anyway, 2019 looks like it could be a really positive year, after all the pain and angst of 2018, here's hoping! |
return to message board, top of board |
Msg # | Subject | Author | Recs | Date Posted |
14733 | Re: Europe | Hasty1 | 3 | 1/16/2019 10:31:56 AM |
14734 | Re: Europe | longusa | 6 | 1/16/2019 12:05:30 PM |
14735 | Re: Europe | jim_pd | 2 | 1/16/2019 12:17:20 PM |