The European Medicines Agency (EMA) has announced that it has started the evaluation of an application submitted by Pfizer Europe for a conditional marketing authorisation for the oral antiviral medicine Paxlovid (PF-07321332 and ritonavir).
The application concerns 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.
According to the announcement, the benefits and risks of Paxlovid will be assessed under a reduced timeline and the EMA’s opinion could be issued within weeks, depending on whether the data submitted are sufficiently robust and whether further information is required to support the evaluation.
The EMA recalls that this expedited timeframe is possible because its human medicines committee (CHMP) has been conducting a rolling review of the data on the medicine, including data from laboratory, animal and clinical studies, as well as data on the quality of the medicine.
The CHMP has also 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.
In parallel, EMA’s safety committee (PRAC) has began the assessment of the risk management plan (RMP) proposed by the company, which outlines measures to identify, characterise and minimise possible risks associated with the medicine.
At the same time, the EMA’s committee for medicines for children (PDCO) issued its opinion on the company’s paediatric investigation plan (PIP), which describes how the medicine should be developed and studied for use in children, in accordance with accelerated timelines for COVID-19 medicines.
If the additional data that has been submitted along this application is considered sufficient and the CHMP concludes 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 conditional marketing authorisation in all EU and EEA Member States.
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 active substance PF- 07321332 blocks the activity of an enzyme needed by the virus to multiply.
The medicine also contains 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.