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EMA receives application for conditional authorisation of first COVID-19 treatment in the EU

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EMA receives application for conditional authorisation of first COVID-19 treatment in the EU

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EMA has now received an application for conditional marketing authorisation (CMA) of the antiviral medicine remdesivir for the treatment of COVID-19 and has formally started its evaluation. The assessment of the benefits and risks of remdesivir is being performed under a reduced timeline and an opinion could be issued within weeks, depending on the robustness of the data submitted and whether further information is required to support the evaluation.

Such a short timeframe will only be possible because some data have already been assessed during the first cycle of the rolling review, which started on 30 April and was concluded on 15 May. During this first phase, EMA scientific committees and working parties operated in synergy to complete their assessment of the dossier significantly earlier compared with a regular evaluation procedure, while still ensuring a robust evaluation of the available data.

During the rolling review, EMA's human medicines committee (CHMP) assessed data on quality and manufacturing, preliminary data from several clinical studies and supporting data from compassionate use programmes. At the conclusion of the first cycle of the rolling review, the CHMP invited the company to submit further data together with an application for a conditional marketing authorisation.

In parallel, EMA's safety committee (PRAC) completed the initial assessment of the preliminary risk management plan (RMP) proposed by the company, which outlines measures to identify, characterise and minimise the medicine's risks. The PRAC will continue to evaluate the safety data for remdesivir in an expedited manner to promptly identify and address potential safety concerns with the medicine.

Furthermore, EMA's committee for medicines for children (PDCO) rapidly issued its opinion on the company's paediatric investigation plan (PIP), which describes how the medicine should be developed and studied for use in children, in accordance with the accelerated timelines for COVID-19 products, and an EMA decision was adopted.

Should the additional data now submitted with the CMA application be sufficient to allow CHMP to conclude that the benefits of remdesivir outweigh its risks in the treatment of COVID‑19, EMA will liaise closely with the European Commission to support fast-tracking of the decision-making process and granting of a marketing authorisation by the European Commission valid in all EU ¹ and EEA Member States.
More about the medicine
Remdesivir is an antiviral medicine which is being investigated for the treatment of COVID-19. Remdesivir is a 'viral RNA polymerase inhibitor' (a medicine that interferes with the production of viral genetic material, preventing the virus from multiplying). It has shown broad in vitro activity against different RNA viruses, including SARS-CoV-2 and was originally developed for the treatment of Ebola virus disease.

Although remdesivir is not yet authorised for marketing in the European Union, it is available to patients through clinical trials and compassionate use programmes, through which patients can get access to unauthorised medicines.

Remdesivir is being developed by Gilead Sciences Ireland CU and is given by infusion (drip) into a vein.
More about the procedure
Further information on how EMA fast-tracks its regulatory procedures so that marketing authorisations of safe, effective and high-quality COVID-19 related medicines can be granted as soon as possible is available.

¹ As of 1 February 2020, the United Kingdom is no longer an EU Member State. However, EU law still applies to the UK during the transition period.

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EMA receives application for conditional authorisation of first COVID-19 treatment in the EU - European Medicines Agency

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EMA has now received an application for conditional marketing authorisation (CMA) of the antiviral medicine remdesivir for the treatment of COVID-19 and has formally started its evaluation. The assessment of the benefits and risks of remdesivir is being performed under a reduced timeline and an opinion could be issued within weeks, depending on the robustness of the data submitted and whether further information is required to support the evaluation.

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Novo coronavírus já circulava na China em outubro 

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Novo coronavírus já circulava na China em outubro 

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https://expresso.pt/coronavirus/2020-05-18-Covid-19.-Novo-coronavirus-ja-circulava-na-China-em-outubro

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Grupo apresenta proposta de Programa Nacional de Transfusão de Plasma

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Grupo apresenta proposta de Programa Nacional de Transfusão de Plasma

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O Governo criou um grupo de trabalho para o desenvolvimento e criação de uma proposta, no prazo de 30 dias, de um Programa Nacional de Transfusão de Plasma Convalescente COVID-19 (PNTPC) para o tratamento de pacientes com COVID-19.

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O Governo criou um grupo de trabalho para o desenvolvimento e criação de uma proposta, no prazo de 30 dias, de um Programa Nacional de Transfusão de Plasma Convalescente COVID-19 (PNTPC) para o tratamento de pacientes com COVID-19. O objetivo é definir os critérios mínimos de inclusão e exclusão dos doentes para entrarem em ensaios clínicos.

Além da definição de critérios de recrutamento de dadores, o grupo irá estabelecer os procedimentos de análise para quantificação de anticorpos neutralizantes virais e para a sua implementação em ensaios clínicos, ou em outras modalidades de estudos clínicos.

O grupo de trabalho é coordenado por Maria Antónia Escoval, Presidente do Conselho Diretivo do Instituto Português do Sangue e da Transplantação (IPST), e conta com responsáveis e peritos da Direção-Geral da Saúde (DGS), do Infarmed - Autoridade Nacional do Medicamento e Produtos de Saúde, do Instituto Nacional de Saúde Doutor Ricardo Jorge (INSA) e integra ainda um membro do Conselho Nacional de Ética para as Ciências da Vida.

Para saber mais consulte o Despacho n.º 5160/2020 - Diário da República n.º 86/2020, Série II de 2020-05-04

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Grupo apresenta proposta de Programa Nacional de Transfusão de Plasma

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O Governo criou um grupo de trabalho para o desenvolvimento e criação de uma proposta, no prazo de 30 dias, de um Programa Nacional de Transfusão de Plasma Convalescente COVID-19 (PNTPC) para o tratamento de pacientes com COVID-19. O objetivo é definir os critérios mínimos de inclusão e exclusão dos doentes para entrarem em ensaios clínicos.

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Anaesthetic machines: off-label use during the COVID-19 pandemic (MDA/2020/012)

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Anaesthetic machines: off-label use during the COVID-19 pandemic (MDA/2020/012)

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SOURCE: Medicines and Healthcare products Regulatory Agency (MHRA)
https://www.gov.uk/drug-device-alerts/anaesthetic-machines-off-label-use-during-the-covid-19-pandemic-mda-2020-012

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DIRETRIZES PARA DIAGNÓSTICO E TRATAMENTO DA COVID-19

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DIRETRIZES PARA DIAGNÓSTICO E TRATAMENTO DA COVID-19

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SOURCE: Secretaria de Ciência, Tecnologia, Inovação e Insumos Estratégicos em Saúde (SCTIE)

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Brasil tem quase 200 voluntários dispostos a se infectar com novo coronavírus em possíveis testes de vacina

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Brasil tem quase 200 voluntários dispostos a se infectar com novo coronavírus em possíveis testes de vacina

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https://g1.globo.com/bemestar/coronavirus/noticia/2020/04/28/brasil-tem-quase-200-voluntarios-dispostos-a-se-infectar-com-novo-coronavirus-em-possiveis-testes-de-vacina.ghtml

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SOURCE: Centers for Disease Control and Prevention (CDC)

https://www.cdc.gov/nCoV

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SOURCE: Taylor & Francis

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As a leading publisher of trusted science, technology, medicine, humanities and social sciences research, Taylor & Francis is committed to helping public health authorities, researchers, clinicians and the general public contain and manage the spread of COVID-19.

This microsite provides links and references to all relevant COVID-19 research articles, book chapters and information that can be freely accessed on Taylor & Francis Online and Taylor & Francis ebooks in support of the global efforts in diagnosis, treatment, prevention and further research into COVID-19. As signatories to NIH's Access to Research initiative, along with the Wellcome Trust's coordinated action on sharing research data and findings relevant to the outbreak, Taylor & Francis has been working with WHO to ensure this content is clearly signposted. We are also aligning the OSTP's initiative to centralise resources on PubMed and are currently working with them to ensure rapid human and machine-readable access (where possible) to research articles and data through the NLM's LitCovid portal.

More research in this field has been collated by colleagues at F1000Research, through a dedicated Gateway which showcases research published in this area, including preprints, to ensure immediate access to the latest research developments https://f1000research.com/gateways/disease_outbreaks/coronavirus
Prioritising rapid publication of COVID-19 materials
We are working with our editors to prioritise peer review of all relevant research. We are also focusing our workflow to ensure that materials related to the outbreak are fast-tracked through the publication process once they are approved. Editors are proactively encouraging authors to publish and share the data that forms the basis of their research in line with FAIR data principles, and our own data policies.

We are continually monitoring the developments of the coronavirus and spread of COVID-19, and we will continue to update the content on this site on a regular basis.

1. W.H. Bassett, Tim Deveaux

2. Edited By Xuefei Ren, Roger Keil

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COVID-19: Novel Coronavirus Content Free to Access

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As a leading publisher of trusted science, technology, medicine, humanities and social sciences research, Taylor & Francis is committed to helping public health authorities, researchers, clinicians and the general public contain and manage the spread of COVID-19.

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SOURCE: World Health Organization (WHO)

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SOURCE: ClinicalTrials.gov
https://clinicaltrials.gov/ct2/results?cond=COVID-19

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Coronavírus: o que você precisa saber e como prevenir o contágio

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Coronavírus: o que você precisa saber e como prevenir o contágio

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SOURCE: Ministério da Saúde
https://coronavirus.saude.gov.br

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SOURCE: World Health Organization
https://www.who.int/emergencies/diseases/novel-coronavirus-2019

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Covid-19. A situação ao minuto do novo coronavírus no país e no mundo

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Covid-19. A situação ao minuto do novo coronavírus no país e no mundo

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SOURCE: RTP
https://www.rtp.pt/noticias/mundo/covid-19-a-situacao-ao-minuto-do-novo-coronavirus-no-pais-e-no-mundo_e1220291

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https://www.mdpi.com/1999-4915/11/3/210

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https://up.pt/covid-19

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Pesquisa indica 3 tipos do novo coronavírus circulando no mundo

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Pesquisa indica 3 tipos do novo coronavírus circulando no mundo

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http://a.msn.com/05/pt-br/BB12ukM4

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https://covid19estamoson.gov.pt

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SOURCE: DW
https://www.dw.com/pt-br/coronavírus/t-52134548

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SOURCE: Ministério da Saúde
https://covid.saude.gov.br

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SOURCE: Ministério da Saúde/DGS
https://covid19.min-saude.pt

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SOURCE: TheGuardian
https://www.theguardian.com/world/series/coronavirus-live

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COVID-19 Dashboard by the Center for Systems Science and Engineering (CSSE) at Johns Hopkins University

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COVID-19 Dashboard by the Center for Systems Science and Engineering (CSSE) at Johns Hopkins University

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https://gisanddata.maps.arcgis.com/apps/opsdashboard/index.html#/bda7594740fd40299423467b48e9ecf6

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FMUP colabora em tecnologia que esclarece dúvidas sobre covid-19

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FMUP colabora em tecnologia que esclarece dúvidas sobre covid-19

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https://noticias.up.pt/fmup-colabora-em-tecnologia-que-esclarece-duvidas-sobre-covid-19

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SOURCE: The Atlantic
https://www.theatlantic.com/health/archive/2020/03/how-will-coronavirus-end/608719

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SOURCE: APhysio
https://facebook.com/APhysiio/photos/a.705020132958281/2724956924297915

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Paciente com doença crônica tem expressão aumentada de gene que facilita infecção pelo coronavírus

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Paciente com doença crônica tem expressão aumentada de gene que facilita infecção pelo coronavírus

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SOURCE: Agência FAPESP
http://agencia.fapesp.br/paciente-com-doenca-cronica-tem-expressao-aumentada-de-gene-que-facilita-infeccao-pelo-coronavirus/32863/?fbclid=IwAR1kf80z8YfWL9VNHV-B9fKIz5-ICCMAFTvBtQ9lgBaMjO7G3AGz7j9CgPs

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SOURCE: European Medicines Agency (EMA)
https://www.ema.europa.eu/en/human-regulatory/overview/public-health-threats/coronavirus-disease-covid-19/treatments-vaccines-covid-19#potential-treatments-under-investigation-section

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COVID-19. Severidade dos sintomas relacionada com a carga viral

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COVID-19. Severidade dos sintomas relacionada com a carga viral

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http://a.msn.com/05/pt-pt/BB11Slyh