3.7M Treatment Courses of PAXLOVID are Planned for Delivery by Early 2023 to Help Combat COVID-19

According to Pfizer, they have reached an agreement with the U.S. Government for the purchase of an additional 3.7 Million treatment courses of its authorized COVID-19 oral medicine, Paxlovid (nirmatrelvir and ritonavir tablets). This agreement supplements the 20 Million treatment courses of antiviral drugs previously delivered to the U.S. Government. The additional 3.7M treatment courses of Paxlovid are planned for delivery by early 2023. 

The medicine Paxlovid is known to combat COVID-19-related hospital stays and death in high-risk patients. Oral medicine is currently authorized for conditional or emergency use in roughly 70 countries all over the world, including the USA. In June of 2022, the company submitted a New Drug Application to the FDA for approval of Paxlovid for those who are at increased risk of progression to severe disease from CORONAVIRUS. The PDUFA action date for a decision by the Food and Drug Administration is in February 2023.

About Paxlovid (Nirmatrelvir Tablets and Ritonavir Tablets):

Paxlovid is a SARS-CoV-2 main protease inhibitor therapy. The medicine was developed to be used orally so that it can be prescribed early after infection, potentially helping patients avoid serious illness (which can lead to hospital stay and death). The medicine Nirmatrelvir is designed to inhibit the activity of the Mpro, an enzyme that the SARS-CoV-2 virus needs to replicate. The administration of Nirmatrelvir with a low dose of ritonavir helps scale down the metabolism, or breakdown, of nirmatrelvir in order for it to remain non-passive in the body for a longer time span at greater concentrations to combat the COVID-19 virus.

The medicine Nirmatrelvir blocks the viral replication at the proteolysis stage, which occurs prior to viral RNA replication. In preclinical studies, nirmatrelvir did not signify signs of mutagenic DNA interactions. Drug Nirmatrelvir has demonstrated consistent in vitro antiviral activity against variants: Alpha, Beta, Delta, Gamma, Lambda, Mu, and Omicron BA.1, BA.2. and BA.4.

Paxlovid is typically used at a dose of 300 mg nirmatrelvir (two 150 mg tablets) with one 100 mg ritonavir tablet, given twice daily for five consecutive days. One carton of this medicine contains five blister packs of Paxlovid, as co-packaged nirmatrelvir tablets with ritonavir tablets, providing all essential doses for a full 5-day treatment course.

Paxlovid is Not Approved But Authorized:

The medicine Paxlovid has not been approved but has been authorized for emergency use by Food and Drug Administration under a EUA, to treat mild-to-moderate CORONAVIRUS in adults and pediatric patients (aged 12 years and older weighing at least 40 kg) with positive outcomes of direct SARS CoV-2 viral testing, and who are at increased risk for progression to severe COVID-19, including hospital stay or death.

The emergency use of this medicine is only authorized for the time span of the edict that situation exists justifying the authorization of the emergency use of drugs and biological products during the COVID pandemic under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1) unless the edict is terminated or authorization revoked sooner. 

Authorized Use of Paxlovid: 

The agency has issued a EUA for the emergency use of the unapproved medicinal product Paxlovid to treat mild-to-moderate COVID-19 in adults and pediatric patients (aged 12 years and older weighing at least 40 kg) with positive results of direct SARS-CoV-2 viral testing, and who are an increased risk for the progression to severe COVID-19 disease, including hospital stay or death.

Limitations:

• The medicine Paxlovid is not authorized for starting treatment in those requiring hospital stay because of serious or critical CORONAVIRUS.
• This anti-viral is not authorized for use as pre/post-exposure prophylaxis in order to prevent CORONAVIRUS.
• This COVID-19 medicine is not authorized for use beyond 5 successive days 

Note: Paxlovid (nirmatrelvir and ritonavir) may only be prescribed for a patient by physicians, advanced practice registered nurses, and physician assistants that are authorized under state law to prescribe the medicines.

Reference:

https://endpts.com/us-set-to-pay-nearly-2b-for-pfizers-covid-19-treatment-paxlovid-in-2023/