EMA has started evaluating an application for fast-tracking authorisation of Pfizer’s COVID-19 oral antiviral medicine Paxlovid.
The application treats mild-to-moderate COVID‑19 in adult and adolescent patients (12 and older weighing at least 40 kg) at high risk of progression to severe COVID‑19.
EMA said it 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 (CHMP) has already started a review of the data on the medicine during a rolling review, which included data from laboratory, animal and clinical studies, and on the quality of the medicine.
In addition, CHMP assessed interim results from the main study on the use of Paxlovid in non-hospitalised, unvaccinated patients with COVID-19.
They had symptomatic disease and at least one underlying condition, putting them at risk of severe disease.
In parallel, EMA’s safety committee (PRAC) started assessing the company’s risk management plan (RMP), which outlines measures to identify, characterise, and minimise the medicine’s risks.
“Should the additional data submitted with the conditional marketing authorisation application be sufficient for CHMP 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 conditional marketing authorisation in all EU and the EEA Member States.”
Paxlovid is an oral antiviral medication that reduces the ability of SARS-CoV-2 to multiply in the body.
The active substance blocks the activity of an enzyme needed by the virus to multiply.
Paxlovid is expected to reduce the need for hospitalisation in patients with COVID-19.
Most people who get COVID probably won’t need treatment, especially if they are vaccinated and don’t have underlying medical conditions.
Plus, omicron appears to cause less severe symptoms than previous variants.
Still, the drugs could be life-saving for those who are unvaccinated, have weakened immune systems, or are vaccinated but at high risk.
Patients should get access to monoclonal antibodies if they were just moderately high risk — such as those who were vaccinated and have diabetes or cardiac conditions.
Pfizer said producing Paxlovid “requires a significant amount of manufacturing capacity” that takes six to eight months, and the company is expanding to ramp up production.
The pills must be taken within the first five days of symptoms.