The European Medicines Agency (EMA) today supported the possible use in an emergency context of Paxlovid, the pill from the pharmaceutical company Pfizer, as an oral treatment for COVID-19, under the individual decision of the national authorities pending an official European license. The pill can be used to treat adults with COVID-19 They do not require supplemental oxygen, but are at increased risk of progressing to severe disease, and should be given as soon as possible after diagnosis, within five days of the onset of symptoms.
The two active ingredients of the medicine, PF-07321332 y ritonavir, which are available as separate tablets, should be taken together twice a day for five days. The advice is based on analysis of interim results from the main study in non-hospitalized, unvaccinated patients who had a symptomatic illness and at least one underlying condition that put them at risk of developing severe COVID-19. “These data showed that Paxlovid reduced the risk of hospitalization and death when treatment was started within five days of the onset of symptoms,” he adds.
None of the patients in the group of 607 people who received Paxlovid died compared to 10 patients from the group of 612 who received placeboWhile in the first group, 6 people were hospitalized within 28 days after starting treatment, compared with 41 in the second group. 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 notes that Paxlovid should not be used with certain medicines., since its action can cause harmful increases in blood levels or, conversely, reduce the activity of this pill. It should not be used in patients with severe kidney or liver failure, nor is its intake recommended during pregnancy, or in people who could become pregnant and are not using contraception. Breastfeeding should also be interrupted during treatment.
Laboratory studies in animals suggest that high doses of Paxlovid may affect the growth of the fetus. The EMA has issued this scientific advice prior to its final decision on the official authorization of this drug to help national authorities decide on the possible early use of the drug, such as in emergency use settings, due to the increasing rates of infections and deaths from COVID-19 in the European Union (EU).
The European agency also announced that a more comprehensive ongoing review of this pill began on Monday to evaluate in real time more comprehensive data on the quality, safety and efficacy of the medicine as it becomes available, an evaluation that will continue until there is sufficient data to request a European license.
The pill “blocks” the activity of a specific enzyme that SARS-CoV-2 it needs to replicate in the infected body, a mechanism similar to that of molnupiravir, the pill developed by MSD (Merck in the US and Canada). Pfizer announced on Tuesday that its pill reduces the risk of hospitalization or death in adults in 89% of cases and indicated that its most recent data confirms that the drug is a “potent inhibitor” against the omicron variant of the coronavirus.
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