AIFA informs that on 10 March 2023 the Scientific Technical Commission decided to suspend the use of the antiviral medicinal product Lagevrio® (molnupiravir) following the negative opinion issued by EMA’S CHMP on 24/02/2023 for the failure to demonstrate a clinical benefit in terms of reduction of mortality and hospitalisations (EMA document available in the “related links” section).

No particular safety issues related to the treatment were detected.

Molnupiravir was initially made available for the treatment of mild-moderate COVID-19 through emergency distribution authorisation pursuant to Article 5.2 of Legislative Decree 219/2006 (Ministerial Decree of 26 November 2021 and subsequent extensions).

The suspension of use will be effective following publication in the Official Gazette.