Press release n° 680 - The Italian Medicine Agency (AIFA) announces that on 22 December 2021, the Scientific-Technical Committee (CTS) authorized two antivirals – molnupiravir and remdesivir- for the treatment of non- hospitalized COVID-19 patients with recent-onset mild to moderate disease and with underlying clinical conditions that may represent specific risk factors for developing severe COVID-19.

Molnupiravir is an oral antiviral (authorized for distribution in emergency conditions with the Decree of the Ministry of Health of 26 November 2021), indicated within 5 days of symptom onset. The treatment should last 5 days, by taking 4 capsules (200mg each) twice a day. The AIFA resolution regarding its use was published in the Official Gazette on 29 December 2021 and is effective as of 30 December 2021. Molnupiravir will be distributed to the Regions by the Special COVID-19 Commissioning Body from January 4 and its prescription is subject to a monitoring registry which will be available shortly on the Agency’s website.

The EMA has recently issued an extension of indications for remdesvir, with regard to the treatment of subjects not requiring supplemental oxygen and at increased risk of progressing to severe COVID-19. The medicine can be used up to 7 days of symptom onset. The treatment should last 3 days, through intravenous administration. Also this therapeutical indication is subject to a monitoring registry, available on the Agency’s website as of 30 December 2021.