The European Medicines Agency (EMA) today recommended granting a conditional marketing authorization to the drug Paxlovid, from the company Pfizer, so it will become the first oral antiviral in the European Union to treat covid-19.
Image from the European Medicines Agency (EMA)
Paxlovid is indicated for “adults who do not require supplemental oxygen and who are at increased risk of the disease becoming severe,” the EMA said in a statement.
Spain has bilaterally acquired 344,000 doses of Paxlovid, which will be added to those that correspond to the centralized purchase made by the EU, the Minister of Health, Carolina Darias, explained yesterday.
This antiviral contains two active ingredients, PF-07321332 and ritonavir, which are administered as two different tablets to be taken once every 24 hours for five days.
The first active ingredient reduces the ability of the virus to multiply in the body, while the second prolongs the action of PF-07321332, that is, it allows it to remain in the body longer.
EMA study with Paxlovid
To reach its conclusion, EMA conducted a study with two groups, one that received Paxlovid and one that was given a placebo.
During the following month, 0.8% (8 of 1,039) of patients who received Paxlovid were hospitalized for more than 24 hours, compared to 6.3% (66 of 1,046) of those who took placebo. There were no deaths in the Pfizer antiviral group, while nine deaths occurred in the second.
“Paxlovid is the first oral antiviral for home use in our portfolio and has the potential to make a real difference for people at high risk of progression to severe covid,” European Commissioner for Health Stella Kyriakides said in a statement after approving the drug.
The EMA had already licensed Paxlovid for emergency cases, under the individual decision of the national authorities.
Pfizer’s drug is the sixth against Sars-CoV-2 authorized in the European Union (anakinra, regdanvimab, tocilizumab, casirivimab/imdevimab, remdesivir and sotrovimab), whose services are analyzing other drugs against the pandemic disease in the initial phase ( ixagevimab/cilgavimab) and another two for prompt authorization (molnupiravir and baricitinib).
“We are making good progress on our second line of defence: promising therapies that can make a real contribution to mitigating the impact of COVID,” the Health Commissioner added in a statement.
Kyriakides added that the Commission continues to work with the Member States to reinforce the therapeutic response against the coronavirus, including the identification of new vaccines after the approval of six prophylactics in the EU (Biontech-Pfizer, Moderna, Astrazeneca, Johnson & Johnson and Novavax). , and another four in the initial phases of analysis (Sputnik V, Sinovac, Sanofi and Valneva).
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