The EMA has started the assessment of the conditional marketing authorisation application for the oral antiviral drug Paxlovid (PF-07321332 and ritonavir). The applicant is Pfizer Europe MA EEIG.
The application is for the treatment of mild to moderate COVID 19 disease in adult and adolescent patients (aged 12 years and older weighing at least 40 kg) at high risk of progression to severe COVID 19 disease.
The EMA will evaluate the benefits and risks of paxlovid in an abbreviated timetable and may issue an opinion within weeks, depending on whether the data submitted are sufficiently robust and whether further information is needed to support the evaluation.
The shortened timetable is feasible as the EMA has already assessed a significant amount of data on the drug during a rolling review in which it evaluated data from laboratory and animal studies, as well as data on the quality of the drug. In addition, the CHMP evaluated data from a study on the effects of Paxlovid in non-hospitalized, unvaccinated patients with COVID-19 disease who had symptomatic disease and at least one underlying condition and who are at increased risk of their disease state progressing to severe.
In parallel, the EMA Safety Committee (PRAC) has initiated an assessment of the company's proposed risk management plan (RMP), which outlines measures to identify, characterize and minimize the risks of the drug. In addition, the EMA's Paediatric Drugs Committee (PDCO) issued its recommendation on the company's paediatric investigation plan (PIP), which outlines how the drug will be developed and studied for use in children, in line with the accelerated timelines for drugs against COVID-19.
If the additional data submitted with the marketing authorisation application is sufficient for the CHMP to conclude that the benefits of Paxlovid outweigh its risks in the treatment of COVID-19, the EMA will work closely with the European Commission to expedite the marketing authorisation approval process which will be valid in all EU and EEA Member States.
The EMA will communicate further during the CHMP opinion.
How the medicine is expected to work
Paxlovid is an oral antiviral medicine that reduces the ability of the SARS CoV 2 virus (the virus that causes COVID-19 disease) to replicate in the body. The active substance PF-07321332 blocks the activity of an enzyme that the virus needs to multiply. Paxlovid also contains a low dose of ritonavir (a protease inhibitor), which slows down the breakdown of PF-07321332, allowing it to stay in the body longer at levels that affect the virus. The drug is expected to reduce the need for hospitalization in patients with COVID-19 disease.
(AF)
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