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