EU regulator could issue decision on Pfizer COVID-19 pill 'within weeks'

The European Union's drug regulator said on Monday it could issue "within weeks" a decision on whether to approve the use of Pfizer's COVID-19 pill, Paxlovid, after the U.S. drugmaker submitted an application seeking authorisation. The approval sought is for the treatment of mild-to-moderate COVID-19 in patients 12 years of age and older, weighing at least 40 kilograms and are at high risk of their illness worsening, the European Medicines Agency said https://www.ema.europa.eu/en/news/ema-receives-application-conditional-marketing-authorisation-paxlovid-pf-07321332-ritonavir-treating.

The European Union's drug regulator said on Monday it could issue "within weeks" a decision on whether to approve the use of Pfizer's COVID-19 pill, Paxlovid, after the U.S. drugmaker submitted an application seeking authorisation.

The approval sought is for the treatment of mild-to-moderate COVID-19 in patients 12 years of age and older, weighing at least 40 kilograms and are at high risk of their illness worsening, the European Medicines Agency said https://www.ema.europa.eu/en/news/ema-receives-application-conditional-marketing-authorisation-paxlovid-pf-07321332-ritonavir-treating. While vaccines are central to the fight against the pandemic, regulators are looking at therapies as a new tool against the fast-spreading Omicron variant, which has now been detected in more than 128 countries around the world.

The EMA has already evaluated a portion of the data during a rolling review of Pfizer's pill that began in November. 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.

In a clinical trial, it was nearly 90% effective in preventing hospitalizations and deaths in patients at high risk of severe illness.