Merck anti Covid pill, Aifa decision and ministry soon

• Anti-Covid pill: Merck asks FDA for authorization

• Jaws: Merck Pill Decreases Risk of Death and Hospitalization

Share

08 November 2021 Aifa and the Ministry are accelerating the decision on the use of the anti Covid pill produced by Merck, another weapon to cure the virus and prevent hospitalizations and deaths. 

The same procedure already followed with monoclonal antibodies last February will be used. The decision will be made shortly. 

The European Medicines Agency (EMA) gave an acceleration, which made it necessary to provide "further guidelines on treatments for Covid in light of the increase in infection rates and deaths".

Molnupiravir is an oral antiviral medicine developed by Merck Sharp & Dohme in collaboration with Ridgeback Biotherapeutics, and has already been authorized in the UK. Examination of the data in real time continues, with a view to a possible application for marketing authorization. 

The medicine works by interfering with the internal replication of the coronavirus. Administration, in the foreseen cases, is recommended as quickly as possible after a positive test, and in any case within 5 days. According to the indications "it can be prescribed to anyone who is tested positive for Covid and has at least one risk factor linked to a possible serious contagion: such as obesity, heart disease, diabetes or over the age of 60". On the application of the categories of patients, Aifa and the ministry will establish the exact methods of use.

While the more comprehensive review is underway (in view of a possible marketing authorization), EMA's Committee for Medicinal Products for Human Use (CHMP) will provide "EU-wide recommendations as soon as possible to help national authorities to decide on the possible early use of the drug, for example in emergency contexts ".