Pfizer said on Wednesday the US Food and Drug Administration (FDA) authorised its antiviral Covid-19 pill, making it the first at-home treatment for the coronavirus that is expected to become an important tool in the fight against the fast spreading Omicron variant.
Data from Pfizer’s clinical trial showed its antiviral regimen was 90 per cent effective in preventing hospitalisations and deaths in patients at high risk of severe illness. Recent lab data suggests the drug retains its effectiveness against Omicron.
The agency said it authorised the oral drug for emergency use for the treatment of mild-to-moderate disease in adults and paediatric patients of 12 years of age and older weighing at least 40kg, or about 88lbs, who are at high risk for progression to severe illness.
"This authorisation provides a new tool to combat Covid-19 at a crucial time . . . and promises to make antiviral treatment more accessible to patients who are at high risk for progression to severe Covid-19," said Patrizia Cavazzoni, director of the FDA's Center for Drug Evaluation and Research.
Prescription only
The drug is available by prescription only and should be initiated as soon as possible after diagnosis of the disease and within five days of symptom onset, said the agency. Pfizer’s Ringaskiddy plant in Cork is slated to play a key role in manufacture of the medicine.
The company said it was ready to start immediate delivery in the US and raised its production projections to 120 million courses of treatment from 80 million in 2022.
The US government’s contract for 10 million courses of the Pfizer drug is priced at $530 (€468) per course.
The pills, taken with the older antiviral drug ritonavir, will be sold under the brand name Paxlovid. They are meant to be taken every 12 hours for five days beginning shortly after the onset of symptoms.
A rival pill from Merck, which is under review by the FDA, has shown lower efficacy compared with Pfizer's treatment. Merck's drug, molnupiravir, reduced hospitalisations and deaths in its clinical trial of high-risk patients by about 30 per cent. – Reuters
