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

Prime monitors the drug pipeline

The drug pipeline is full of new, groundbreaking drugs that may help members live better and feel well. Prime focuses on clinical strategies designed to keep clients ahead of drug trends — because it’s easier to manage change when you see it coming.


  1. National Institute of Health (NIH) Coronavirus Disease 2019 (COVID-19) Treatment Guidelines. Last updated May 31, 2022. Available at:
  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: Accessed June 16, 2022.
  4. Covid in the U.S.: Latest Maps, Case and Death Counts – The New York Times ( Updated Sept. 2, 2022: Accessed at:
  5. What to Do If You Are Sick | CDC. Updated March 22, 2022. Accessed at:
  6. Coronavirus disease 2019 (COVID-19) Treatment Guidelines. National Institutes of Health. Last updated May 31, 2022. Page 45. Available at:
  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:
  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:

Related news


May 15, 2024

High-Cost Therapy Profile

Detailed information about Fidanacogene elaparvovec-dzkt Intravenous (IV)


May 15, 2024

June 2024 decisions expected from the FDA

Your monthly synopsis of new drugs expected to hit the market


May 15, 2024

Oncology Insights: First-in-class bladder cancer therapy and the Bacillus Calmette-Guérin (BCG) shortage

Approximately 83,000 new bladder cancer cases are diagnosed in the U.S. in each year. Here’s a look at the recent advancements and treatment options for bladder cancer, as well as an update on the BCG shortage.