The distribution to the Regions by the commissioner of the antiviral pill developed by the American pharmaceutical giant Merck Sharp & Dohme in partnership with Ridgeback Biotherapeutics began today. At the end of December, the Italian Medicines Agency (Aifa) had given the green light to the drug for the treatment of non-hospitalized patients, with mild-moderate disease that has manifested itself for a few days and in the presence of clinical conditions that represent specific risk factors for the development of severe disease.
Method of administration
It is an oral antiviral (authorized for distribution in emergency conditions by decree of the Ministry of Health of November 26, 2021) whose use is indicated within five days of the onset of symptoms. The duration of the treatment, which consists of taking 4 tablets (200 mg) twice a day, is 5 days. The Aifa determination relating to the methods of use was published on 29 December 2021 in the Official Gazette. On the American market, the cost of a cycle amounts to around 700 dollars.
Effectiveness revised in progress
Molnupiravir was the first pill drug indicated for the treatment of coronavirus infection to be registered. The British regulatory agency (MHRA) first authorized it on 4 November. On November 26, the pharmaceutical company announced that the drug is 30% effective, which is less than the preliminary phase 3 studies which instead indicated a 50% risk reduction.
Green disc also to remdesivir
At the same time, remdesivir, an antiviral drug produced by the US pharmaceutical company Gilead Sciences, developed for the treatment of infections from Ebola and Marburg viruses was given green light by Aifa. Following its discovery, other studies have been done to explore other applications of the antiviral profile, including that against the SARS-CoV-2 coronavirus. For remdesivir, an extension of the indication was recently authorized by Ema relating to the treatment of subjects who are not on oxygen therapy, at high risk of severe Covid. The drug can be used for up to seven days after the onset of symptoms. It is administered intravenously and the treatment lasts three days. Also for this new indication the use of a monitoring register is foreseen which is accessible on the Aifa website.