Astrazeneca tries its luck in Covid-19 prevention

 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. https://www.evaluate.com/vantage/articles/news/snippets/astrazeneca-tries-its-luck-covid-19-prevention