(Reuters.) The European Union’s drug regulator stated Monday that it can issue within weeks a decision regarding whether the approval of use of a substance is granted. Pfizer (NYSE:) Paxlovid is a COVID-19-based pill. This was after the U.S. drugmaker filed an application for authorisation.

The European Medicines Agency stated that the approval was sought to treat mild-to-moderate covid-19 in patients aged 12 or older who are less than 40kg and at risk of having their condition worsen.

While vaccinations are essential in fighting the pandemic, regulatory authorities are now looking into therapies to combat the rapidly-emerging Omicron variant. It has been found in over 128 countries.

During a rolling review that Pfizer began in November and included data from the pill, the EMA had already assessed a portion.

Pfizer’s two-drug regimen called Paxlovid, which is meant to be taken at home for five days soon after onset of COVID-19 symptoms, was authorized for people aged 12 and older by the U.S. Food & Drug Administration in December.

Clinical trials showed that it nearly 90% of patients who were at highest risk for severe illness died or had their hospitalizations prevented.