EMA recommendations on compassionate use of remdesivir for COVID-19
Posted: 6 April 2020 | Hannah Balfour (European Pharmaceutical Review) | No comments yet
The European Medicines Agency has released recommendations about which patients could benefit from remdesivir and the possible criteria for compassionate use of the drug.
The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has given recommendations on how remdesivir should be used in compassionate use programmes for treating the COVID-19 coronavirus.
Estonia, Greece, the Netherlands and Romania requested that the CHMP give their opinion on the conditions under which early access to remdesivir through compassionate use could be given to patients with COVID 19. Remdesivir is an RNA polymerase inhibitor that has shown activity against SARS-CoV-2, the coronavirus causing the COVID-19 pandemic, SARS-CoV and MERS-CoV in laboratory studies, but there is limited clinical trial data at the moment.
Compassionate use programmes enable patients to access treatments without a marketing authorisation if they have a life-threatening, long-lasting or seriously disabling disease with no available treatment options. COVID-19 can cause pneumonia, severe acute respiratory syndrome, multi-organ failure and death in severe cases and since there are no currently approved therapies, could qualify for compassionate use programmes.
“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.”
The CHMP guidelines aim to ensure a common criteria is adopted for the conditions under which remdesivir is used prior to authorisation of compassionate use programmes being set up by EU Member States.
The recommendations are intended to guide EU countries considering setting up a compassionate use programme and are not mandatory. They describe which patients may benefit from remdesivir, how to use remdesivir and give preliminary information on its safety.
Click here for the EMA’s summary on compassionate use and conditions of use of remdesivir.
Clinical Development, Drug Markets, Regulation & Legislation, Research & Development (R&D), Therapeutics
Committee for Medicinal Products for Human Use (CHMP), The European Medicines Agency (EMA)