The European Medicines Agency said the tablets should be taken twice a day for five days. Her advice will help member states decide on possible early use of the drug before wider approval in the light of the increasing number of coronavirus cases.
The most common side effects are diarrhea, nausea, dizziness and headache, and headache.
In parallel, EMA is conducting a phased review of molnupiravir before a possible manufacturer’s application for an EU-wide marketing authorization.
Molnupiravir is an oral antiviral medicine that reduces the ability of the virus to multiply in the body by increasing the number of mutations in the genetic material of the virus.
Also on Friday, the EMA announced the commencement of the evaluation process of the oral drug Paxlovid produced by the American concern Pfizer.
EMA has so far approved three drugs for Covid-19 on the European market. The first – Veklury, which disrupts the production of viral RNA – in July 2020. Two more – Ronapreve and Regkirona, based on monoclonal antibodies – November 11 this year.
Four more drugs are awaiting approval by the EMA. Two of them are monoclonal antibodies (RoActemra and Xevudy) and the other two (Olumiant and Kineret) are immunosuppressants.
In addition, the Agency is undergoing a phased review of two more drugs: the aforementioned oral molnupiravir and the Evusheld monoclonal antibody.
Deliveries to Poland in December
Last week, a spokesman for the Ministry of Health informed that patients at high risk of the tragic course of COVID-19 will be given the drug Molnupiravir, which is to be delivered to Poland by mid-December.
– We have contracted deliveries of the drug Molnupiravir – that is several tens of thousands of units, which should be delivered in December – said Wojciech Andrusiewicz. He expressed his hope that it would reach Poland by the middle of next month.
Andrusiewicz assured that it is a drug with high effectiveness “even exceeding 50% in the fight against covid”. He specified that this drug must be used in the first five days. “It is a home medicine and at the moment, together with the representatives of the Medical Council, we are analyzing how to start administering it,” he added.
– Patients are strictly indicated – these are patients at high risk of a rather tragic course of the disease, i.e. these are patients from risk groups to whom we should administer this drug – emphasized Andrusiewicz.