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EMA has received application for conditional marketing authorization of remdesivir

EMA has received application for conditional marketing authorization of remdesivir EMA has received application for conditional marketing authorization of remdesivir
EMA has received application for conditional marketing authorization of remdesivir EMA has received application for conditional marketing authorization of remdesivir

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In the EU (European Union), EMA (European Medicines Agency) has received an application for conditional authorization of remdesivir.

For SARS-CoV-2 management, EMA (European Medicines Agency) has obtained a CMA (conditional marketing authorization) application of remdesivir and has rapidly initiated its evaluation. Remdesivir, an antiviral medicine, is being investigated for mitigating the outcomes of COVID-19. It is a viral RNA polymerase inhibitor that hinders the production of viral genetic material. This hampers viral multiplication.


Under a reduced timeline, the benefit-risk evaluation of remdesivir is being carried out. Based on whether additional information is required to assist the evaluation and the robustness of the submitted data and, an opinion may be issued within weeks.


During the first cycle of the rolling review (30 April 2020-15 May 2020), some of the data has already been examined. During this first phase, EMA working parties and scientific committees operated together to promptly complete their assessment of the dossier, while still ensuring a robust assessment of the available data.


Data were assessed by EMA’s CHMP (Committee for Medicinal Products for Human Use) on the basis of preliminary data from numerous clinical studies, quality and manufacturing, and supporting data from compassionate use programmes during the rolling review. In the end, the CHMP invited the company to submit additional data along with a CMA application.


EMA’s PRAC (Pharmacovigilance Risk Assessment Committee) has completed the initial examination of the preliminary RMP (risk management plan) offered by the company. PRAC will continue the assessment of the medicine's safety data to rapidly identify, characterize and diminish remdesivir’s risks, and address its potential safety issues.


Furthermore, EMA’s PDCO (Paediatric Committee) published its opinion on the company’s PIP (pediatric investigation plan). It provides information on how medicine should be developed and studied for usage in children, in accordance with the accelerated timelines for COVID-19 products.


EMA will liaise closely with the EC (European Commission) to determine whether the submitted data is sufficient to allow CHMP to conclude that the benefits of remdesivir outweigh its risks in coronavirus management. This will aid the granting of a marketing authorization by the EC valid in all EU1and EEA Member States.


In the EU, remdesivir has not yet received authorization for marketing. However, unauthorized medicines are accessible to patients through clinical trials and compassionate use programmes. Gilead Sciences Ireland CU is developing remdesivir and is administered by infusion (drip) into a vein.

Source:

European Medicines Agency

Article:

https://www.ema.europa.eu/en/news/ema-receives-application-conditional-authorisation-first-covid-19-treatment-eu

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