Paxlovid New Drug Application with the FDA

Emergency use authorization (EUA) granted in December 2021; now COVID-19 treatment on track for official FDA approval.

September 21, 2022
Estimates suggest more than 94 million people in the U.S. have had COVID-19, with more than 1 million fatalities, a rate of 314 per 100,000.4  The count of known cases in early September 2022 sits around 90,000 per day; about 40% of those are hospitalized.4

Drug name:             Paxlovid™ (nirmatrelvir/ritonavir)
Manufacturer:         Pfizer
Condition:               Treatment of COVID-19 in individuals over 12 years old at high risk for progression to severe illness

Condition overview:
In a report on more than 370,000 confirmed COVID-19 cases with reported symptoms in the United States, 70% of patients experienced fever, cough, or shortness of breath; 36% had muscle aches; and 34% reported headaches.3 Other reported symptoms have included, but are not limited to, diarrhea, dizziness, rhinorrhea, anosmia, dysgeusia, sore throat, abdominal pain, anorexia, and vomiting.

COVID-19 is an infectious disease caused by the SARS-CoV-2 virus. COVID-19 can produce a spectrum of illness ranging from asymptomatic infection to severe pneumonia with acute respiratory distress syndrome (ARDS) and death. Anyone can acquire COVID-19, but according to the U.S. Centers for Disease Control (CDC) 50-60% of the U.S. population have at least one risk factor for progressing to severe COVID-19 illness. These risk factors include, but are not limited to: being aged 65 and older, obesity, diabetes, hypertension, smoking, physical inactivity, chronic kidney or liver disease, and immunocompromised conditions.1,2

Current treatment:
Symptomatic management such as acetaminophen are recommended for mild symptoms of COVID.5

For patients who are at high risk of progressing to severe COVID-19 (preferred therapies) listed in order of preference:

  • Paxlovid (nirmatrelvir/ritonavir): Taken orally twice daily for five days.
  • Veklury® (remdesivir): Remdesivir is an intravenous infusion administered by a health care professional with a WAC of $3,120 for a typical course.

Alternative therapies. These are recommended for use ONLY when neither of the preferred therapies are available, feasible to use, or clinically appropriate. Listed in alphabetical order:

  • bebtelovimab: Bebtelovimab is administered by a health care professional as a single intravenous injection. The WAC is $2,100 per dose.
    • The U.S. government will exhaust their supply of bebtelovimab as early as the week of August 22.
  • Lagevrio™ (molnupiravir): Molnupiravir is taken orally twice daily for 5 days.
    • The U.S. government bought 3.1 million courses (~$700/course).

Overview of Paxlovid
Nirmatrelvir/ritonavir is a combination of two viral protease inhibitors which work to prevent COVID-19 virus replication.7 In a clinical study, patients treated within three days of symptom onset had a 89% relative risk reduction in the rate of hospitalization or death.

Incidence of adverse events was similar between nirmatrelvir/ritonavir and placebo treatment arms in the trial. Ritonavir, one component of the product, has many known drug-drug interactions with medications including anticoagulants, antiarrhythmics, and anticonvulsants. Because of this potential safety risk, evaluation of a patient’s medication regimen and dose adjustment may be required.

According to the CDC, a brief return of symptoms may be part of the natural history of SARS-CoV-2 infection in some persons independent of treatment with nirmatrelvir/ritonavir and regardless of vaccination status. Patients treated with nirmatrelvir/ritonavir who experience COVID-19 rebound generally have had mild illness. There is no current evidence that additional treatment is needed with nirmatrelvir/ritonavir or other therapies in cases where COVID-19 is suspected.8,9

 PDFUA date:    4th quarter 2022
Benefit:             Pharmacy benefit, oral administration

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References

  1. National Institute of Health (NIH) Coronavirus Disease 2019 (COVID-19) Treatment Guidelines. Last updated May 31, 2022. Available at: https://files.covid19treatmentguidelines.nih.gov/guidelines/covid19treatmentguidelines.pdf
  2. Hammond J, Leister-Tebbe H, Gardner A, et al. Oral Nirmatrelvir for High-Risk, Non-hospitalized Adults with COVID-19. N Engl J Med 2022;386:1397-1408.
  3. Food and Drug Administration. Coronavirus disease 2019 (COVID-19) emergency use authorizations for medical devices. 2021. Available at: https://www.fda.gov/medical-devices/emergency-use-authorizationsmedical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices. Accessed June 16, 2022.
  4. Covid in the U.S.: Latest Maps, Case and Death Counts – The New York Times (nytimes.com). Updated Sept. 2, 2022: Accessed at: https://www.nytimes.com/interactive/2021/us/covid-cases.html
  5. What to Do If You Are Sick | CDC. Updated March 22, 2022. Accessed at: https://www.cdc.gov/coronavirus/2019-ncov/if-you-are-sick/steps-when-sick.html
  6. Coronavirus disease 2019 (COVID-19) Treatment Guidelines. National Institutes of Health. Last updated May 31, 2022. Page 45. Available at: https://files.covid19treatmentguidelines.nih.gov/guidelines/covid19treatmentguidelines.pdf
  7. Food and Drug Administration (FDA) Emergency Use Authorization (EUA). Paxlovid (nirmatrelvir co-packaged with ritonavir). Issued December 22, 2021; reissued March 17, 2022, April 14, 2022, and July 6, 2022.
  8. COVID rebound: COVID-19 rebound after Paxlovid treatment.Accessed in August 2022 at: https://emergency.cdc.gov/han/2022/pdf/CDC_HAN_467.pdf
  9. Wang, L, Berger NA, Davis PB, et al. COVID-19 rebound after Paxlovid and molnupiravir during January-June 2022. Accessed in August 2022 at: https://www.medrxiv.org/content/10.1101/2022.06.21.22276724v1.full

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