Pfizer has initiated rolling submission with the EMA to obtain authorisation for the therapy. Credit Lucio Alfonsi / Pixabay.

The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the usage of Pfizer’s oral antiviral, Paxlovid (nirmatrelvir plus ritonavir), to treat adult Covid-19 patients.

According to the advice, Paxlovid is intended for use in people who do not need supplemental oxygen but are at greater disease progression risk.

Go deeper with GlobalData

Premium Insights

The gold standard of business intelligence.

Find out more

Related Company Profiles

View all

Paxlovid is an experimental inhibitor of SARS-CoV-2 protease.

The CHMP noted that the oral antiviral should be given immediately after diagnosing Covid-19 and within five days of symptom onset.

With the recommendation, EU member states’ authorities can decide on permitting the distribution and usage of Paxlovid in advance of conditional marketing authorisation from the EU.

Additionally, Pfizer has commenced rolling submission with the EMA to obtain authorisation for Paxlovid.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

The latest advice is based on favourable interim data from the Phase II/III EPIC-HR clinical trial of the oral drug in adult Covid-19 patients who are not hospitalised but are at high disease progression risk.

Findings showed that Paxlovid demonstrated an 89% decline in disease-associated hospital admission or mortality from any cause versus placebo within three days from when symptoms are developed.

A similar trend was reported in individuals who received the treatment within five days of the symptom development.

Last week, the company reported final analysis data from the trial of Paxlovid.

Pfizer chairman and CEO Albert Bourla said: “The CHMP’s advice signifies the strength of our data for Paxlovid in the treatment of high-risk adults diagnosed with Covid-19.

“If authorised, Paxlovid has the potential to help save lives and reduce hospitalisations. We look forward to working with the EMA and other regulatory agencies worldwide to bring this potential treatment to patients as quickly as possible.”