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EMA Issues Guidance On Compassionate Use Of Remdesivir For COVID-19 Cover Image

The European Medicines Agency has released recommendations on how Gilead Sciences’ investigational antiviral medicine remdesivir should be used via compassionate use programs to treat COVID-19 in the EU.

In two newly published documents, the agency explains the conditions under which early access to remdesivir could be given through compassionate use programs to patients with COVID‑19 who are not eligible for inclusion in clinical trials that are testing the product for coronavirus disease. In severe cases, COVID-19 can cause pneumonia, severe acute respiratory syndrome, multi-organ failure and death.

The recommendations were published on 3 April after Estonia, Greece, the Netherlands and Romania in late March asked the agency’s drug evaluation committee, the CHMP, to issue an opinion on the matter.

They come in the form of a summary on compassionate use  and a conditions of use document, and are aimed at EU member states that are considering setting up compassionate use programs for the use of remdesivir for COVID-19.

The recommendations, the EMA said, are designed to ensure a common approach regarding the criteria and conditions of the product’s use before member states authorize such programs. In addition to describing which patients may benefit from the medicine, they explain how to use remdesivir and give preliminary information on its safety.

Remdesivir, which was originally developed for treating Ebola virus disease, has shown broad in vitro activity against different RNA viruses, including SARS-CoV-2, and is currently being tested in clinical trials for the treatment of COVID-19.

The EMA said that while "clinical trials remain the gold standard for the collection of robust data on the safety and effectiveness of investigational medicinal products,” the CHMP “acknowledges the need for a harmonized approach to compassionate use in the EU to allow access to remdesivir for patients who are not eligible for inclusion in clinical trials.”

It added that the CHMP encouraged Gilead to make remdesivir available in “a fair and transparent way to those member states wishing to take part in international clinical trials or treat patients in compassionate use programs.”

Compassionate Use Programs In EU

Compassionate use programs are intended for patients with a life-threatening, long-lasting or seriously disabling disease and no available treatment options. They give access to treatments that are still under development and have not yet received a marketing authorization.

In the EU, these programs are set up at the level of individual member states. National competent authorities can ask the EMA for an opinion on how to administer, distribute and use certain medicines for compassionate use under Article 83 of Regulation (EC) No 726/2004.

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