EMA advises on compassionate use programs for remdesivir

Regulatory NewsRegulatory News | 03 April 2020 |  By 

The European Medicines Agency (EMA) on Friday released a set of recommendations for providing Gilead’s investigational drug remdesivir under compassionate use programs to patients with coronavirus disease (COVID-19) who are ineligible for clinical trials.
EMA says it received requests from four EU member states, Estonia, Greece, the Netherlands and Romania, asking for advice on providing early access to the drug.
Initially developed as an antiviral therapy to treat Ebola, remdesivir emerged as an early candidate to treat COVID-19 and is being studied in multiple clinical trials, including in the US and China, and is being provided to some US patients through an expanded access treatment protocol.
In two documents released alongside the announcement, EMA lays out a recommended conditions and criteria for providing remdesivir via compassionate use programs prior to the drug being authorized more broadly in the EU. “In addition to describing which patients may benefit from the medicine, the recommendations explain how to use remdesivir and give preliminary information on its safety,” EMA writes.
EMA notes that the recommendations are not mandatory for member states and stresses that clinical trials for the drug should be prioritized for patients who are eligible.
“Clinical trials remain the gold standard for the collection of robust data on the safety and effectiveness of investigational medicinal products, but the [Committee for Medicinal Products for Human Use] CHMP acknowledges the need for a harmonised approach to compassionate use in the EU to allow access to remdesivir for patients who are not eligible for inclusion in clinical trials,” said CHMP Chair Harald Enzmann.


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