FDA finally approves Pfizer's new corona oral treatment

The US Food and Drug Administration (FDA), which regulates medicines in the United States, has announced that it has issued an emergency use authorization for Pfizer's new coronavirus infection (COVID-19) oral treatment 'PAXLOVID'. Pfizer's oral treatment is prescribed within 5 days of onset in patients aged 12 years or older and weighing 40 kg or more at high risk of COVID-19 aggravation.

Coronavirus (COVID-19) Update: FDA Authorizes First Oral Antiviral for Treatment of COVID-19 | FDA
https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-first-oral-antiviral-treatment-covid-19

FDA gives emergency authorization to Pfizer's COVID-19 pill | Ars Technica
https://arstechnica.com/science/2021/12/fda-gives-emergency-authorization-to-pfizers-covid-19-pill/

Paxrovid, developed by Pfizer, is a combination of 'nilmatrelvir ( PF-07321332 ) ' and ' ritonavir ' that block the activity of the enzyme required for the new coronavirus to self-replicate. In November 2021, Pfizer published an interim report of a Phase II / III clinical trial stating that 'the risk of hospitalization or death from COVID-19 was reduced by 89%,' and applied for an emergency use authorization with the FDA.

Pfizer announces that administration of the new corona treatment 'Paxlobido' reduced the risk of hospitalization and death by 89% --GIGAZINE

Paxlobido is highly effective for patients in the early stages of COVID-19 onset, and it is said that it is a rule to take 2 tablets of Nirmatrelvir and 1 tablet of ritonavir twice a day for a total of 30 tablets for 5 days. In addition, Paxrovid is not permitted to be used for more than 5 consecutive days.

Dysgeusia, diarrhea, hypertension, muscle pain, etc. have been reported as side effects, and when used by people infected with human immunodeficiency virus type 1 (HIV-1), it may lead to drug resistance to HIV-1. And that. Also, ritonavir can cause liver damage, so caution should be exercised when administering it to patients with liver disease or hepatitis, the FDA said.

'With the approval of Paxlobid, we have introduced the first treatment for COVID-19 in the form of orally ingestible tablets, which is the world's largest new coronavirus,' said Dr. Patrizia Cabazzoni, director of the FDA's Pharmaceutical Center. A major step forward in the fight against the epidemic. This approval provides a new tool for combating COVID-19 at key times in the pandemic, with a high risk of COVID-19 aggravation as new variants emerge. We promise to make it easier for patients to receive anti-virus treatment. '

Pfizer states that less than 200,000 doses will be available by the end of the year and will produce 120 million doses by the end of 2022.

The COVID-19 oral treatment ' molnupiravir ' developed by the pharmaceutical company Merck was approved for emergency use in the United Kingdom and the EU in November 2021, but is still under review in the United States. ..