Pfizer wins first-stage approval for Paxlovid for high-risk covid patients

US Food and Drug Administration says data supports the drug's use and on Thursday the FDA will discuss giving it full approval

Pfizer’s plant in Ringaskiddy, Co Cork, which manufactures Paxlovid. File picture 

The US health regulator’s staff reviewers said data from Pfizer’s covid-19 drug trials supports its use in adults at high risk of progressing to severe disease.

The Food and Drug Administration (FDA) made its assessment in briefing documents ahead of a meeting of the agency’s external advisers on Thursday to discuss full approval to use Pfizer’s oral pill for high-risk covid-19 patients patients exhibiting mild to moderate symptoms.

The FDA’s advisers will vote on whether the benefits related to Paxlovid outweigh its risks.

The agency typically follows the advice of its expert advisers, but is not mandated to do so.

Paxlovid has been authorised for emergency use since late 2021, and a full approval is likely to allow Pfizer to expand its advertising campaign for the drug.

Over 12m courses have been delivered to US pharmacies, and US patients have used over 8m courses of the treatment, according to US federal data.

There have been multiple reports on rebounds in some people after taking Paxlovid.

US president Joe Biden and Anthony Fauci, then director of the US National Institute of Allergy and Infectious Diseases, both experienced a rebound last year after taking the medicine.

However, during mid-to-late stage trials of the drug, overall rates of symptom rebound ranged from 10% to 16%, with no evidence of a higher rebound rate in patients who received the drug or the placebo, regardless of their risk to severe disease, or whether Omicron or an earlier variant was dominant, the reviewers said.

Paxlovid, taken for five days beginning shortly after onset of covid-19 symptoms, has shown reduction in risk of hospitalisation or death by 86% in non-hospitalised, high-risk adult patients in the Pfizer study, which did not include vaccinated participants.

• Reuters