Albert Bourla, CEO of Pfizer, speaks to a press conference after a visit to monitor the production of the Pfizer-BioNtech COVID-19 vaccine at the US pharmaceutical company Pfizer’s factory in Puurs, Belgium, on April 23, 2021.
John Thys | Swimming pool | Reuters
Pfizer filed an application with the Food and Drug Administration on Tuesday for emergency approval of its Covid-19 treatment pill, saying it reduces hospital stays and deaths by 89% when given with a popular HIV drug.
The pill, if approved by the FDA, could help revolutionize the fight against Covid by allowing high-risk people infected with the virus to take an oral antiviral drug at home instead of going to the hospital. Such treatment could help ease the burden on hospital systems during the pandemic.
In a clinical study of people aged 18 and over who were at increased risk of developing severe Covid, the pill reduced hospital stays and deaths by 89% when taken within three days of symptoms appearing. according to Pfizer.
The pill, known as paxlovid, blocks the activity of an enzyme that the virus needs to replicate. Paxlovid is used in combination with a low-dose ritonavir, an HIV drug, to slow the patient’s metabolism down so that the drug can stay active in the body at a higher concentration for longer to fight the virus.
Pfizer said the Covid treatment was shown to be safe, adding that study participants taking paxlovid reported fewer adverse events than the placebo, and most of them were “mild intensity”.
If approved, paxlovid is given in two 150 mg tablets with one 100 mg tablet of ritonavir twice a day.
“We are working hard to get this potential treatment into patients’ hands as soon as possible and look forward to working with the US FDA to review our application as well as other regulatory agencies around the world,” said Pfizer Das said CEO Albert Bourla in a statement on Tuesday.
Bourla had previously said that Pfizer planned to file its data with the FDA before Thanksgiving.
Early Tuesday, Pfizer announced that it would allow generic drug companies to ship their antiviral pill to 95 low and middle income countries.
Merck is also developing an antiviral pill, molnupiravir, to fight Covid. The company found in an interim analysis that the pill reduced the risk of hospitalization and death in adults with mild to moderate Covid by 50%.
Merck, which co-developed the drug with Ridgeback Biotherapeutics, filed an application with the FDA for approval of the pill last month.
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