EMA’s recommendation on compassionate use of SBECD-enabled remdesivir for COVID-19 and Update from Gilead

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During an extraordinary virtual meeting held on 2 April 2020, EMA’s human medicines committee (CHMP) gave recommendations on how the investigational antiviral medicine remdesivir should be used for treating coronavirus disease (COVID-19) in compassionate use programmes in the European Union.

Compassionate use programmes, which are set up at the level of individual EU Member States, are intended to give patients with a life-threatening, long-lasting or seriously disabling disease and no available treatment options, access to treatments that are still under development and that have not yet received a marketing authorisation.

In this case Estonia, Greece, the Netherlands and Romania requested an opinion from the CHMP on the conditions under which early access to remdesivir through compassionate use could be given to patients with COVID‑19. In severe cases, COVID-19 can cause pneumonia, severe acute respiratory syndrome, multi-organ failure and death.

“Clinical trials remain the gold standard for the collection of robust data on the safety and effectiveness of investigational medicinal products, but the 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 Dr Harald Enzmann, the chair of the CHMP. “The CHMP encourages the company 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 programmes.”


An Update on COVID-19 from Gilead’s Chairman & CEO

Over the course of the past week, Gilead has been working in consultation with regulatory authorities to establish additional expanded access programs for remdesivir, an investigational medicine for COVID-19. The programs enable hospitals or physicians to apply for emergency use of remdesivir for multiple severely ill patients at a time. These are patients who cannot take part in clinical trials and where the word “emergency” is all too real for them, their families and the healthcare providers advocating on their behalf.

New U.S. sites have been initiated and Gilead is adding more on an ongoing basis. In addition to the expanded access programs, Gilead continues to provide remdesivir on an individual compassionate use basis for children and pregnant women. More than 1,700 patients have now been treated through these programs.

Remdesivir is still an investigational medicine and has not been approved by regulatory authorities anywhere in the world. This is why multiple clinical trials for remdesivir are underway, involving thousands of patients with COVID-19 across the world.

Supply and Donation of Remdesivir

A critical part of Gilead’s responsibility today is ensuring sufficient supply of remdesivir. To provide product for trials, compassionate use and expanded access, Gilead needed to effectively start from ground zero in ramping up supplies. The progress made on this to date is thanks to the actions taken since January to rapidly expand production and increase supply. The existing supply, including finished product ready for distribution as well as investigational medicine in the final stages of production, amounts to 1.5 million individual doses. Depending on the optimal duration of treatment, which is something studied in clinical trials, this supply could equate to well over 140,000 treatment courses for patients.

Gilead is providing the entirety of this existing supply at no cost, to treat patients with the most severe symptoms of COVID-19. The 1.5 million individual doses are available for compassionate use, expanded access and clinical trials and will be donated for broader distribution following any potential future regulatory authorizations. These doses are for treating patients with severe symptoms, through daily intravenous infusions in a hospital setting. Having a potential treatment in our hands comes with significant responsibility. Providing existing supplies at no charge is the right thing to do, to facilitate access to patients as quickly as possible and in recognition of the public emergency posed by this pandemic.

Over the next weeks and months, Gilead will be able to further increase supplies of remdesivir as raw materials with long lead times become available for manufacture. They have set an ambitious goal of producing more than 500,000 treatment courses by October and more than 1 million treatment courses by the end of this year.

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. Due to its limited aqueous solubility, sulfobutyl-ether-beta-cyclodextrin is used as en excipient to enable the formulation.

Remdesivir is being developed by Gilead Sciences Ireland CU and is given by infusion (drip) into a vein.


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