EMA באקומט אַפּלאַקיישאַן פֿאַר קאַנדישאַנאַל פֿאַרקויף דערלויבעניש פֿאַר Paxlovid (PF-07321332 און ריטאָנאַוויר) פֿאַר טרעאַטינג פּאַטיענץ מיט COVID-19

The European Medicines Agency (EMA) has started evaluating an application for a קאַנדישאַנאַל פֿאַרקויף דערלויבעניש for the oral antiviral medicine Paxlovid (PF-07321332 and ritonavir). The applicant is Pfizer Europe MA EEIG.

The application is for the treatment of mild-to-moderate COVID 19 in adult and adolescent patients (12 years of age and older weighing at least 40 kg) who are at high risk of progression to severe COVID 19.

EMA will assess the benefits and risks of Paxlovid under a reduced timeline and could issue an opinion within weeks, depending on whether the data submitted are sufficiently robust and whether further information is required to support the evaluation.

Such an expedited timeframe is only possible because EMA’s human medicines committee (טשמפּ) has already started a review of the data on the medicine during a ראָולינג אָפּשאַצונג, which included data from laboratory, animal and clinical studies, as well as data on the quality of the medicine. In addition, טשמפּ assessed interim results from the main study on the use of Paxlovid in non-hospitalised, unvaccinated patients with COVID-19 who had symptomatic disease and at least one underlying condition putting them at risk of severe disease.¹

In parallel, EMA’s safety committee (PRAC) started the assessment of the ריזיקירן פאַרוואַלטונג פּלאַן (RMP) proposed by the company, which outlines measures to identify, characterise and minimise the medicine’s risks. Furthermore, in accordance with the accelerated timelines for COVID-19 products EMA’s committee for medicines for children (פּדקאָ) issued its opinion on the company’s paediatric investigation plan (פּיפּ), which describes how the medicine should be developed and studied for use in children.

Should the additional data submitted with the קאַנדישאַנאַל פֿאַרקויף דערלויבעניש application be sufficient for טשמפּ to conclude that the benefits of Paxlovid outweigh its risks in the treatment of COVID 19, EMA will liaise closely with the European Commission to fast track the decision granting a קאַנדישאַנאַל פֿאַרקויף דערלויבעניש in all EU and EEA member states.

EMA will communicate further at the time of טשמפּ’s opinion.

אַדווערטייזמאַנט

How is the medicine expected to work?

Paxlovid is an oral antiviral medicine that reduces the ability of SARS-CoV-2 (the virus that causes COVID-19) to multiply in the body. The אַקטיוו מאַטעריע PF-07321332 blocks the activity of an enzyme needed by the virus to multiply. Paxlovid also supplies a low dose of ritonavir (a protease inhibitor), which slows the breakdown of PF-07321332, enabling it to remain longer in the body at levels that affect the virus. Paxlovid is expected to reduce the need for hospitalisation in patients with COVID-19.

Based on an interim analysis of this study, EMA issued advice on the use of Paxlovid for treating COVID-19 in December 2021.

פֿאַרבונדענע צופרידן

• Article 5(3) opinions: Use of Paxlovid (PF-07321332 and ritonavir) for treating COVID-19
• EMA issues advice on use of Paxlovid (PF-07321332 and ritonavir) for the treatment of COVID-19: rolling review starts in parallel (קסנומקס / קסנומקס / קסנומקס)
• Paediatric investigation plan
• COVID-19 טריטמאַנץ
• COVID-19 treatments: under evaluation
• COVID-19: לעצטע דערהייַנטיקונגען
• קאַמיטי פֿאַר מעדיסינאַל פּראָדוקטן פֿאַר מענטשלעך נוצן (טשמפּ)
• פאַרמאַקאָוויגילאַנסע ריזיקירן אַסעסמאַנט קאַמיטי (פּראַק)

שער דעם אַרטיקל: