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On June 30, 2022, pharmaceutical giant Pfizer Inc. (PFE) announced that it had filed a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its oral COVID-19 treatment Paxlovid. The drug is currently authorized for emergency use for the treatment of COVID in adults and children 12 years of age and older in certain cases.

The NDA process is a critical step toward a drug’s approval and commercialization in the U.S. Companies seeking formal approval of a pharmaceutical product for sale and marketing must submit an NDA application with information regarding safety, effectiveness, labeling, and more. Paxlovid received emergency use authorization from the FDA in December 2021 as the first oral antiviral for the treatment of COVID-19.

On July 6, 2022, following Pfizer’s NDA submission, the FDA revised its Emergency Use Authorization for Paxlovid, authorizing pharmacists to prescribe it to eligible patients, although with some limitations. Patients testing positive for COVID-19 will need to provide certain health records and a list of medications to a pharmacist to be screened for eligibility. Pharmacists may either prescribe Paxlovid or should refer patients for further clinical evaluation.

Key Takeaways

  • Pfizer submitted a New Drug Application for Paxlovid, its oral antiviral COVID-19 treatment, on June 30.
  • The drug, which already has received emergency approval by the FDA, reduces the risk of hospitalization or death by up to 88% in certain cases.
  • On July 6, the FDA authorized pharmacists to prescribe Paxlovid to eligible patients, with some limitations.
  • Paxlovid users occasionally experience rebounding COVID-19 symptoms, which may have hampered initial sales of the drug.
  • Still, Pfizer projected $22 billion in Paxlovid revenue for FY 2022 in its Q1 2022 earnings report.

Phase 2/3 Study Shows Significant Reduction of Hospitalization and Death Risk

Pfizer says that a Phase 2/3 Evaluation of Protease Inhibition for COVID-19 in High-Risk Patients (EPIC-HR) study has found that Paxlovid treatment reduces the risk of hospitalization or death by 88% in adult patients treated within the first five days of symptom onset, when compared with placebo. Pfizer added that the “novel primary endpoint of self-reported, sustained alleviation of all symptoms for four consecutive days” was not achieved. Pfizer’s application aims for approval of Paxlovid as a treatment in both vaccinated and unvaccinated patients who are at high risk for progression to severe illness due to COVID-19. Up to 60% of the U.S. population may have at least one risk factor for this progression.

Significant Sales Potential, But Some Hindrances

Paxlovid may be among the fastest-selling drug treatments of all time, with analytics firms Airfinity Ltd. predicting almost $24 billion in revenue for Paxlovid in 2022 as of April. However, some patients have found a recurrence of COVID-19 symptoms following Paxlovid treatment. This may have contributed to somewhat-lackluster Paxlovid sales of $1.5 billion for Q1 2022, although Pfizer in its earnings report for that quarter reaffirmed its guidance for $22 billion in FY 2022 Paxlovid sales.

If Pfizer receives NDA approval for Paxlovid, this may further bolster sales in 2022 and beyond. Patients who may be hesitant to take a drug treatment with emergency approval only could be swayed by more-formal approval by the FDA. Together with Comirnaty, Pfizer’s COVID-19 vaccine, Paxlovid already is projected to account for more than half of the company’s total revenue in 2022. NDA approval could drive further growth in this area. It is not immediately clear when Paxlovid may receive NDA approval.

Bottom Line

Pfizer submitted a New Drug Application for Paxlovid, its oral antiviral treatment for COVID-19. The company cited Phase 2/3 study results indicating up to 88% reduction in risk of hospitalization or death in adults treated within five days of first symptoms. While Paxlovid has experienced hindrances associated with COVID-19 rebounds after treatment, NDA approval could bolster sales. Paxlovid received emergency authorization from the FDA in December 2021.

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