The Committee for Medicinal Products for Human Use of the European Medicines Agency (EMA) has endorsed the use of ‘Paxlovid’, Pfizer’s antiviral for the treatment of COVID-19.
According to the conclusions of the European regulatory body, the drug, which was not yet authorized in the EU, can be used to treat adults with COVID-19 who do not require supplemental oxygen and who are at increased risk of progressing to serious illness.
‘Paxlovid’ should be administered as soon as possible after the diagnosis of COVID-19 and within 5 days of the onset of symptoms. The two active substances in the medicine, PF-07321332 and ritonavir, which are available as separate tablets, must be taken together twice a day for 5 days.
The EMA has issued this recommendation so that national authorities can decide on the possible early use of the medicine before marketing authorization, for example, in emergency use situations, in light of the increasing rates of infection and deaths from the drug. COVID-19 across the EU.
This recommendation is based on interim results of a study conducted in non-hospitalized, unvaccinated patients with symptomatic disease and at least one underlying condition that put them at risk for severe COVID-19.
These data showed that ‘Paxlovid’ reduced the risk of hospitalization and death when treatment was started within 5 days of the onset of symptoms. Approximately 1 percent of patients (6 out of 607) who took this antiviral within 5 days of symptom onset were hospitalized within 28 days of initiation of treatment, compared with 6.7 percent of patients. patients (41 out of 612) given placebo (a dummy treatment); none of the patients in the ‘Paxlovid’ group died, compared with 10 patients in the placebo group.
Regarding safety, the most common side effects reported during treatment and up to 34 days after the last dose were dysgeusia (taste disturbance), diarrhea, and vomiting.
The EMA specifies that ‘Paxlovid’ should not be used with some other medicines, either because due to its action it can cause a harmful increase in its blood levels, or because, conversely, some medicines can reduce the activity of the antiviral itself. ‘Paxlovid’ should also not be used in patients with severely reduced liver or kidney function.
It is also not recommended during pregnancy and in people who could become pregnant and who do not use contraception. Breastfeeding should be stopped during treatment. These recommendations are because laboratory studies in animals suggest that high doses of ‘Paxlovid’ may affect fetal growth.
‘Paxlovid’ is an oral antiviral medicine that reduces the multiplying capacity of SARS-CoV-2 (the virus that causes COVID-19) in the body. The active substance PF-07321332 blocks the activity of an enzyme necessary for the virus to multiply. Paxlovid also provides a low dose of ritonavir (a protease inhibitor), which slows down the breakdown of PF-07321332, allowing it to stay in the body for longer at levels that affect the virus. ‘Paxlovid’ is expected to reduce the need for hospitalization for COVID-19 patients.