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EMA recommends conditional marketing authorisation for Paxlovid

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EMA approva la pillola trattamento Covid Pfizer  Paxlovid

EMA recommends conditional marketing authorisation for Paxlovid / Pillola trattamento Covid di Pfizer (Paxlovid)

EMA, 27/01/2022

Autorizzaione AIFA

AIFA aveva già autorizzato in anticipo su EMA l'uso con il Decreto 26 novembre 2021 Autorizzazione alla temporanea distribuzione dei farmaci antivirali molnupiravir e paxlovid. (GU n. 295 del 13.12.2021)

The product information for Paxlovid - available here - contains information for healthcare professionals, a package leaflet for members of the public and details of conditions of the medicine’s authorisation.

EMA approva la pillola trattamento Covid di Pfizer (Paxlovid)

EMA’s human medicines committee (CHMP) has recommended granting a conditional marketing authorisation for the oral antiviral medicine Paxlovid (PF-07321332 / ritonavir) for the treatment of COVID-19. The applicant is Pfizer Europe MA EEIG.

The Committee recommended authorising Paxlovid for treating COVID-19 in adults who do not require supplemental oxygen and who are at increased risk of the disease becoming severe.

Paxlovid is the first antiviral medicine to be given by mouth that is recommended in the EU for treating COVID-19. It contains two active substances, PF-07321332 and ritonavir, in two different tablets. PF-07321332 works by reducing the ability of SARS-CoV-2 (the virus that causes COVID-19) to multiply in the body while ritonavir prolongs the action of PF-07321332 enabling it to remain longer in the body at levels that affect the multiplication of the virus.

In reaching its conclusion, the CHMP evaluated data from a study involving patients with COVID-19 showing that treatment with Paxlovid significantly reduced hospitalisations or deaths in patients who have at least one underlying condition putting them at risk of severe COVID-19. The analysis was done in patients who received Paxlovid or placebo (dummy treatment) within 5 days after COVID-19 symptoms began and who did not receive, nor were expected to receive, treatment with antibodies. Over the month following treatment, the rate of hospitalisation or death1 was 0.8% (8 out of 1,039) for patients who received Paxlovid, compared with 6.3% (66 out of 1,046) for those who received placebo. There were no deaths in the Paxlovid group and 12 deaths2 in the placebo group.

The majority of patients in the study were infected with the Delta variant. Based on laboratory studies, Paxlovid is also expected to be active against Omicron and other variants.

The safety profile of Paxlovid was favourable and side effects were generally mild. However, ritonavir is known to affect the action of many other medicines, and warnings and advice have been included in Paxlovid’s product information. In addition, the company has provided a drug interaction tool on its website which can be accessed through a QR code included in the product information and on the outer carton. A letter will be sent to relevant healthcare professionals’ organisations to further remind them of the issue. The CHMP concluded that the medicine’s benefits are greater than its risks for the approved use and will now send its recommendations to the European Commission for a rapid decision applicable in all EU Member States. 

The product information for Paxlovid - available here - contains information for healthcare professionals, a package leaflet for members of the public and details of conditions of the medicine’s authorisation.
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Scarica questo file (Comunicato AIFA 684 Paxlovid.pdf)Comunicato AIFA 684 Paxlovid
 
IT143 kB43
Scarica questo file (2021.01.27 EMA_COVID-19 EMA raccomanda AIC Paxlovid IT.pdf)2021.01.27 EMA_COVID-19 EMA raccomanda AIC Paxlovid IT
 
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Scarica questo file (Product information for Paxlovid.pdf)Product information for Paxlovid
 
IT705 kB349

Tags: Coronavirus

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