MRx Pipeline +: COVID-19 Oral Antiviral Front Runners

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DECEMBER 2021

MRx PIPELINE

COVID-19 Oral Anitviral Front Runners

At Magellan Rx Management, we are dedicated to providing you with timely and valuable information surrounding COVID-19. As the global pandemic approaches its second year, and amidst emerging variants, both preventive and acute treatment options will be crucial in its defeat. SARS-CoV-2 immunization continues across the US and has significantly lessened the incidence and severity of COVID-19 cases. The antiviral remdesivir (Veklury®) is FDA-approved to treat acute COVID-19 in select hospitalized patients with COVID-19; it is administered IV in a hospital or comparable setting. Three injectable monoclonal antibody regimens that are administered IV or SC are FDA-authorized for acute treatment of mild to moderate COVID-19 and/or PEP in individuals who are at risk for developing severe COVID-19 illness. The availability of oral antiviral agents that inhibit SARS-CoV-2 virus replication could be a turning point in the war against the pandemic. While COVID-19 vaccines remain the best prevention against SARS-CoV-2, oral agents have the potential to provide at-home acute treatment as well as PEP in susceptible populations. The MRx Pipeline+ provides a credible clinical snapshot of promising COVID-19 oral antiviral candidates in the US. DRUG NAME DEVELOPER

TARGET

APPROXIMATE PARTICIPANTS

AGE

DOSAGE

SCHEDULE

COMMENTS

EUA

MARKET DYNAMIC

Submitted to FDA molnupiravir (Lagevrio) Merck/ Ridgeback PF-07321332 + ritonavir (Paxlovid) Pfizer

Ribonucleoside analog

1,433

≥ 18 years

800 mg twice daily x 5 days

Start within 5 days of symptom onset

Reduced risk of hospitalization or death by 30%* in non-hospitalized, high-risk adults with mild-moderate COVID-19; ongoing trial for PEP

Pending ─ authorization anticipated in December 2021 for at-risk, non-hospitalized, symptomatic adults; on 11/30/21 AMDAC voted in favor of authorization

~$700 per course of treatment

Protease inhibitor

2,100

≥ 18 years

300 mg PF-07321332 + 100 mg ritonavir twice daily x 5 days

Start within 5 days of symptom onset

Reduced risk of hospitalization or death by 85%** in non-hospitalized, high-risk adults; ongoing studies in low-risk adults and for PEP

Pending ─ authorization anticipated for at-risk, non-hospitalized, symptomatic adults; AMDAC review TBD

~$530 per course of treatment

Phase 3 study AT-527 Atea

carrimycin Shenyang Tonglian favipiravir Dr. Reddy's/ Appili/Global Response Aid FZCO

RNA viral polymerase inhibitor

1,386

≥ 12 years

1,100 mg twice daily x 5 days

TBD

Outpatient setting for mild-moderate COVID-19; study amended to assess hospitalization or death in high-risk patients; results expected in 2H 2022

Potential submission in 2022

TBD

Macrolide antibiotic

300

≥ 18 years

400 mg once daily x 14 days

TBD

Hospital setting for severe COVID-19

TBD

TBD

RNA polymerase inhibitor

1,231

≥ 18 years

N/A

TBD

No significant improvement in time to sustained clinical recovery was demonstrated in mild-moderate COVID-19; additional analyses are ongoing

TBD

TBD

1,092 (379 with confirmed COVID-19)

≥ 12 years

300 mg twice daily x 5 days

TBD

Reduced risk of progression of mildmoderate COVID-19 to severe illness by 85%; NIH recommends use only as part of a clinical trial; ongoing PEP study

TBD

TBD

nitazoxanide ER Broad-spectrum Lupin/Romark antiparasitic

The list is not all-inclusive. Peer-reviewed studies have NOT been published for the featured oral antiviral candidates. * Risk of hospitalization or death was reduced by ~50% in the interim analysis and by ~30% in the full study population. ** Risk of hospitalization and death was reduced by 89% and 85% when given within 3 and 5 days, respectively, of symptom onset. GLOSSARY AMDAC – Antimicrobial Drugs Advisory Committee COVID-19 – Coronavirus Disease 2019 ER – Extended-Release EUA – Emergency Use Authorization FDA – Food and Drug Administration

H – Half IV – Intravenously N/A – Not Available NIH – National Institutes of Health PEP – Post-Exposure Prophylaxis

SARS-CoV-2 – Severe Acute Respiratory Syndrome Coronavirus 2 SC – Subcutaneously TBD – To Be Determined US – United States

EDITORIAL STAFF Maryam Tabatabai, Pharm D VP, Clinical Information

Carole Kerzic, RPh Drug Information Pharmacist