Astrazeneca tries its luck in Covid-19 prevention

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Astrazeneca’s filing for emergency use of AZD7442 for Covid-19 prevention looks like an attempt to steal a march on Regeneron and Lilly’s already authorised MAbs. Whether it will succeed is a separate question. Astra says “AZD7442 (could) be the first long-acting MAb to receive an EUA for Covid-19 prevention”, though Regeneron’s Regen-Cov and Lilly’s bamlanivimab/etesevimab, both normal-acting, already have EUAs for post-exposure prophylaxis in subjects at high risk of severe Covid-19. Astra’s application appears to seek a broad EUA for Covid-19 prevention, even though only its pre-exposure study, Provent, succeeded; Storm Chaser, for post-exposure prophylaxis, failed. A separate question for the FDA will be whether to authorise AZD7442 in vaccinated as well as unvaccinated people; the Regeneron and Lilly prophylaxis EUAs are for unvaccinated people and those who are vaccinated but unable to mount a strong immune response, but Astra’s trials were specifically in the unvaccinated population. A similar consideration exists for Merck & Co’s oral antiviral molnupiravir, which last week scored in a Covid-19 treatment study in unvaccinated people. While it might seem unethical to deny a drug based on patients’ vaccination status, reimbursement for molnupiravir might be justifiable only in its specific studied population.

Selected antivirals & MAbs for treating Covid-19 
Project  Company  Setting  Trial Vaccinated people allowed?
Molnupiravir Merck & Co/Ridgeback  Outpatient treatment Move-Out, succeeded No*
Post-exposure prophylaxis Move-Ahead, data H1 2022 No
AT-527 Roche/Atea Outpatient treatment Morningsky, ends Nov 2021 Yes if vaccinated >40 days previously
PF-07321332 Pfizer Low-risk outpatient treatment NCT05011513, ends Oct 2021 No, except those with underlying condition
High-risk outpatient treatment NCT04960202, ends Nov 2021 No
Post-exposure prophylaxis NCT05047601, data H1 2022  No
Favipiravir Appili Outpatient treatment Preseco, ends Sep 2021 Yes
RHB-107 (upamostat) Redhill Biopharma Outpatient NCT04723537, ends Sep 2022 Yes
AZD7442  Astrazeneca Post-exposure prophylaxis Storm Chaser, failed No
Pre-exposure prophylaxis Provent, succeeded No
Outpatient treatment Tackle, data H2 2021 No
Regen-Cov (casirivimab + imdevimab) Regeneron Treatment (has EUA) COV-20678 No
Post-exposure prophylaxis (has EUA**) COV-2069 Yes
Bamlanivimab + etesevimab Lilly/Abcellera Treatment (has EUA) Blaze-4 Yes, except low-risk individuals
Post-exposure prophylaxis (has EUA**) Blaze-2, part 1 No
Source: Evaluate Pharma & clinicaltrials.gov. Notes: *per Wolfe Research, not specified on clinicaltrials.gov; **in unvaccinated people, or vaccinated people unable to mount strong immune response.

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