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EMA's CHMP has recommended the use of remdesivir, an investigational antiviral medicine, in compassionate use programs across the European Union.
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended the use of remdesivir, an investigational antiviral medicine, in compassionate use programs across the European Union.
As reported in an April 3, 2020 press release, CHMP’s recommendation was given in a virtual meeting held on April 2, 2020, and means that patients with COVID-19 can be administered remdesivir through compassionate use. The recommendation describes which patients may benefit from the early use of the medicine, how to use the medicine, and preliminary information on the safety of the medicine.
“Clinical trials remain the gold standard for the collection of robust data on the safety and effectiveness of investigational medicinal products, but 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,” said Dr. Harald Enzmann, the chair of the CHMP, in the press release. “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 programs.”