British drug major AstraZeneca (AZN.L,AZN) announced Thursday that new analyses of two AZD7442 COVID-19 Phase III trials in high-risk populations confirmed robust efficacy and long-term prevention.
The company noted that new data from the AZD7442 COVID-19 PROVENT prevention and TACKLE outpatient treatment Phase III trials both showed robust efficacy from a one-time intramuscular or IM dose of the long-acting antibody or LAAB combination.
The six-months follow-up of the ongoing PROVENT trial showed 83 percent reduced risk of symptomatic COVID-19 compared to placebo, with no severe disease or deaths with AZD7442.
The AZD7442 PROVENT trial is the first Phase III trial prospectively designed to evaluate a monoclonal antibody for pre-exposure prophylaxis of symptomatic COVID-19.
Further, a exploratory analysis of the TACKLE outpatient treatment trial, in patients with mild-to-moderate COVID-19, showed 88 percent reduced risk of severe COVID-19 or death in patients who had been symptomatic for three days or less at the time of treatment.
The company noted that AZD7442 was generally well tolerated in both PROVENT and TACKLE trials. No new safety issues were identified in the six-month analysis of PROVENT.
AstraZeneca will submit full results from PROVENT and TACKLE for publication in a peer-reviewed medical journal and presented at a forthcoming medical meeting.
In early October, the company submitted a request to the US Food and Drug Administration for Emergency Use Authorisation or EUA for AZD7442 for prophylaxis of COVID-19.
AstraZeneca has agreed to supply the US Government with 700,000 doses of AZD7442 if granted an EUA by the FDA, and has agreements to supply to other countries.
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