Australia recently granted provisional determination for AstraZeneca’s COVID-19 monoclonal antibody (mAb) cocktail postexposure prophylaxis (PEP) therapy Evusheld (tixagevimab + cilgavimab / AZD7442). On expected successful provisional approval and launch in early 2022, it faces competition with a crowded COVID-19 armory of mAb and oral anti-viral therapies, says GlobalData, a leading data and analytics company.

So far, Australia provisionally approved three treatments: Roche’s casirivimab + imdevimab (Ronapreve) in October 2021 both as symptomatic therapy and PEP therapy, GSK’s Sotrovimab (Xevudy) in August 2021 as symptomatic therapy in mild-to-moderate patient setting, and Gilead’s remdesivir (Veklury) in July 2020 as therapy for patients hospitalized with severe COVID-19 symptoms.

Sasmitha Sahu, Pharma Analyst at GlobalData, comments: “As Australia enters the vaccination consolidation phase of its national plan with over 80% vaccination, it is now expediting the evaluation of COVID-19 therapies to ensure access to promising therapies.”

Australia is one of the many countries that have reported all the four variants of COVID-19. Both Ronapreve and Evusheld were found to neutralize recent emergent variants, including the Delta variant in preclinical studies.

Sahu continues: “mAb therapies, particularly cocktail therapies, become important in the wake of COVID-19 virus showing significantly quick mutations. PEP therapies will be different from vaccines because they are intended for use in people who have been exposed to the virus and are at risk of developing symptoms or complications regardless of previous vaccination. As such, they will be positioned ahead of the first line of treatment in COVID-19 management.”

According to the GlobalData Pharma Intelligence Center, there are seven COVID-19 therapies in Phase I and above in Australia and there are no other mAb cocktails under evaluation.

Roche’s tocilizumab, Celltrion’s regdanvimab, MSD’s oral antiviral molnupiravir, which are under evaluation for provisional approval, and Pfizer’s PF-07321332 + ritonavir oral anti-viral combination, which received provisional determination, are expected to be the next therapies set to enter the Australian market, pending expected provisional approval in early 2022. Australia has already purchase agreements in place not only for Ronapreve, Xevudy, and Veklury but also for molnupiravir and ritonavir.

Evusheld and regdanvimab showed 77% and 72% reduction in risk, respectively, in developing symptomatic COVID-19 while Ronapreve significantly reduced viral load in seronegative patients with symptomatic COVID-19 who did not require oxygen support. Oral antiviral therapies like PF-07321332 + ritonavir, and molnupiravir are also now being evaluated for PEP in advanced trials.

Sahu concludes: “All the PEP therapies have almost similar results in reducing risks of COVID-19 hospitalization and death. With many PEP mAbs and oral therapies already included in Australia’s National Medical Stockpile and oral therapies now being evaluated for PEP, competition for Evusheld appears imminent.”