LG
Gaertner
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http://www.ema.europa.eu/docs/en_GB/...Agenda/2017/07/WC500231582.pdf
Unter B.4. EPARs/WPARs (Seite 39):
EPAR
Der European Public Assessment Report wird von der Europäischen Arzneimittelagentur EMA für jedes für ein zentrales Zulassungsverfahren eingereichtes Arzneimittel für die Human- oder Veterinärmedizin erstellt und veröffentlicht. Kernstück ist die wissenschaftliche Diskussion, in welcher das Nutzen-Risiko-Verhältnis umfassend abgewogen wird. Sie schließt mit einer positiven oder negativen Empfehlung (positive/negative opinion) des Ausschusses, auf die sich die Erteilung oder Ablehnung der Arzneimittelzulassung durch die Europäische Kommission gründet.[1]
Quelle: Wikipedia
Weitere Informationen von der europäischen Arzneimittelagentur:
http://www.ema.europa.eu/ema/index.jsp?curl=pages/...ntent_000433.jsp
25 von 30 Stimmen für Positiv!!!
Seite 12 Minutes of the CHMP meeting 19-22.06.2017
3.1.2. Fotivda - tivozanib - EMEA/H/C/004131
EUSA PHARMA; treatment of adult patients with advanced renal cell carcinoma (RCC) Scope: Opinion
Action: For adoption
New active substance (Article 8(3) of Directive No 2001/83/EC)
List of Outstanding Issues adopted on 26.01.2017. List of Questions adopted on 21.07.2016.
The Committee confirmed that all issues previously identified in this application had been addressed.
The Committee adopted a positive opinion recommending the granting of a marketing authorisation by majority (25 positive out of 30 votes) together with the CHMP assessment report and translation timetable.
Furthermore, the CHMP considered that tivozanib hydrochloride monohydrate is a new active substance, as claimed by the applicant.
The Icelandic Member was in agreement with the CHMP recommendation and the Norwegian Member was not.
The divergent position (Agnes Gyurasics, Alar Irs, Bruno Sepodes, Johann Lodewijk Hillege, Sinan B. Sarac, Svein Rune Andersen) was appended to the opinion.
The legal status was agreed as medicinal product subject to medical prescription. The summary of opinion was circulated for information.
The CHMP adopted the assessment report on similarity.
http://www.ema.europa.eu/ema/index.jsp?curl=pages/...0b01ac058004d5c3
AVEO Oncology Announces FOTIVDA® (tivozanib) Approved in the European Union for the Treatment of Advanced Renal Cell Carcinoma
http://www.aveooncology.com/wp-content/uploads/...ozanib-Approval.pdf
The European Medicines Agency has cleared once-daily VEGF inhibitor tivozanib under the Fotivda brand name as a front-line treatment in adult RCC patients. That means it can be used in patients whose disease has progressed one line of cytokine therapy with interleukin-2 or interferon, provided they have not previously been treated with other drugs including VEGF or mTOR inhibitors.
The EMA approval is based on the results of the TIVO-1 trial, in which tivozanib was found to be better than Bayer/Onyx's VEGF inhibitor Nexavar (sorafenib) in extending progression-free survival (PFS) with fewer side effects. The FDA thought was not up to scratch when it turned down the drug in 2013, but the EMA's advisory committee interpreted the data differently, recommending approval earlier this year.
http://www.fiercebiotech.com/biotech/...rug-tivozanib-rises-up-europe
AVEO Oncology Announces Receipt of Payments from EUSA Pharma and CANbridge
http://www.nasdaq.com/press-release/...a-and-canbridge-20170913-00256
AVEO Oncology and EUSA Pharma Announce TiNivo Combination Study Opt-in
http://www.nasdaq.com/press-release/...ion-study-optin-20170920-00292
AVEO Oncology Announces Completion of TIVO-3 Study Futility Analysis with No Changes to Study Protocol
http://www.nasdaq.com/press-release/...hanges-to-study-20171005-01266
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Wertung | Antworten | Thema | Verfasser | letzter Verfasser | letzter Beitrag | |
49 | Aveo Oncology - geht da was? | Balu4u | Vassago | 19.01.23 10:27 | ||
4 | 335 | Aveo Pharmaceuticals Next Hit ? | MasterbrokerUSA | twotto | 25.04.21 03:03 |