Drugs / AZD7442
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | — | COVID-19 | 2021-10-05 | “AstraZeneca has submitted a request to the US Food and Drug Administration (FDA) for an Emergency Use Authorization (EUA) for AZD7442” astrazeneca.com ↗ |
Trials 3
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT05166421 | Nov 2021 → Jul 2023 | COVID-19 | AstraZeneca | Completed | Mixed |
| Phase 32 trials · 1 met primary · 1 missed | ||||||
| Phase 3 | NCT04625972 | Dec 2020 → Apr 2021 | COVID-19 | AstraZeneca | Completed | Missed primary |
| Phase 3 | NCT04625725 | Nov 2020 → Aug 2022 | COVID-19 | AstraZeneca | Completed | Met primary |
News releases announcing trial results or a regulatory action · 18
| Date | Issuer | Release |
|---|---|---|
| 2022-10-20 | AstraZeneca | Results IDWeek data reinforces AstraZeneca’s commitment to advance science in vaccines and immune therapies astrazeneca.com ↗
Additional analyses from TACKLE Phase III treatment trial further demonstrate Evusheld’s potential to reduce COVID-19 severity and mortality |
| 2022-09-20 | AstraZeneca | Regulatory Evusheld long-acting antibody combination approved in the EU for the treatment of COVID-19 astrazeneca.com ↗ |
| 2022-09-16 | AstraZeneca | Regulatory Evusheld long-acting antibody combination recommended for approval in the EU for the treatment of COVID-19 astrazeneca.com ↗
AstraZeneca's Evusheld (tixagevimab and cilgavimab, formerly AZD7442), a long-acting antibody combination, has been recommended for marketing authorisation in the European Union (EU) for the treatment of adults and adolescents (aged 12 years and older weighing at least 40 kg) with COVID‑19 who do not require supplemental oxygen and who are at increased risk of progressing to severe COVID‑19. |
| 2022-08-30 | AstraZeneca | Regulatory Evusheld long-acting antibody combination approved for prevention and treatment of COVID-19 in Japan astrazeneca.com ↗
AstraZeneca's Evusheld (tixagevimab and cilgavimab, formerly AZD7442), a long-acting antibody combination, has been approved in Japan for both prevention (pre-exposure prophylaxis) and treatment of symptomatic disease caused by SARS-CoV-2 infection. |
| 2022-06-08 | AstraZeneca | Results Evusheld significantly prevented COVID-19 disease progression or death in TACKLE Phase III treatment trial astrazeneca.com ↗ |
| 2022-04-20 | AstraZeneca | Results Evusheld significantly protected against symptomatic COVID-19 for at least six months in PROVENT Phase III trial in high-risk populations astrazeneca.com ↗
Detailed results from the PROVENT Phase III pre-exposure prophylaxis (prevention) trial showed that AstraZeneca’s Evusheld (tixagevimab and cilgavimab), formerly AZD7442, reduced the risk of developing symptomatic COVID-19 by 77% in the primary analysis and by 83% in the six month follow-up analysis, compared to placebo. |
| 2022-03-28 | AstraZeneca | Regulatory Evusheld long-acting antibody combination approved in the EU for pre-exposure prophylaxis (prevention) of COVID-19 in a broad population astrazeneca.com ↗ |
| 2022-03-24 | AstraZeneca | Regulatory Evusheld long-acting antibody combination recommended for approval in the EU for the pre-exposure prophylaxis (prevention) of COVID-19 astrazeneca.com ↗ |
| 2022-03-17 | AstraZeneca | Regulatory AstraZeneca’s antibody combination, Evusheld▼ (tixagevimab co-packaged with cilgavimab) authorised for use in Great Britain for pre-exposure prophylaxis (prevention) of COVID-19 astrazeneca.com ↗
AstraZeneca's Evusheld ▼ (tixagevimab co-packaged with cilgavimab) is authorised by the Medicines and Healthcare products Regulatory Agency (MHRA) and is the first antibody combination for pre-exposure prophylaxis (PrEP) against COVID-19 licensed in Great Britain. |
| 2021-12-23 | AstraZeneca | Results Evusheld long-acting antibody combination retains neutralising activity against Omicron variant in studies from Oxford and Washington Universities astrazeneca.com ↗
Evusheld’s Inhibitory Concentration 50 (IC50), a measure of neutralising potency of an antibody, was 273 ng/ml and 147 ng/ml in the Oxford and Washington University studies, respectively. |
| 2021-12-16 | AstraZeneca | Results Evusheld long-acting antibody combination retains neutralising activity against Omicron variant in independent FDA study astrazeneca.com ↗ |
| 2021-12-08 | AstraZeneca | Regulatory Evusheld (formerly AZD7442) long-acting antibody combination authorised for emergency use in the US for pre-exposure prophylaxis (prevention) of COVID-19 astrazeneca.com ↗
AstraZeneca's Evusheld (tixagevimab co-packaged with cilgavimab), a long-acting antibody (LAAB) combination, has received emergency use authorisation (EUA) in the US for the pre-exposure prophylaxis (prevention) of COVID-19, with first doses expected to become available very soon. |
| 2021-11-18 | AstraZeneca | Results New analyses of two AZD7442 COVID-19 Phase III trials in high-risk populations confirm robust efficacy and long-term prevention astrazeneca.com ↗
In an analysis of the ongoing PROVENT trial evaluating a median six months of participant follow-up, one 300mg IM dose of AZD7442 reduced the risk of developing symptomatic COVID-19 compared to placebo by 83%. |
| 2021-10-11 | AstraZeneca | Results AZD7442 reduced risk of developing severe COVID-19 or death in TACKLE Phase III outpatient treatment trial astrazeneca.com ↗
Positive high-level results from the TACKLE Phase III COVID-19 treatment trial showed AstraZeneca's AZD7442, a long acting antibody (LAAB) combination, achieved a statistically significant reduction in severe COVID-19 or death compared to placebo in non-hospitalised patients with mild-to-moderate symptomatic COVID-19. |
| 2021-10-05 | AstraZeneca | Regulatory AZD7442 request for Emergency Use Authorization for COVID-19 prophylaxis filed in US astrazeneca.com ↗
AstraZeneca has submitted a request to the US Food and Drug Administration (FDA) for an Emergency Use Authorization (EUA) for AZD7442, its long-acting antibody (LAAB) combination, for prophylaxis of symptomatic COVID-19. |
| 2021-09-27 | AstraZeneca | Results AstraZeneca COVID-19 and RSV presentations at IDWeek 2021 will showcase scientific progress in infectious diseases astrazeneca.com ↗
The data showed that AZD7442 compared to placebo achieved a statistically significant reduction in the risk of developing symptomatic COVID-19 prior to virus exposure (pre-exposure prophylaxis). |
| 2021-08-20 | AstraZeneca | Results AZD7442 PROVENT Phase III prophylaxis trial met primary endpoint in preventing COVID-19 astrazeneca.com ↗
Positive high-level results from the PROVENT Phase III pre-exposure prophylaxis trial showed AstraZeneca's AZD7442 achieved a statistically significant reduction in the incidence of symptomatic COVID-19, the trial's primary endpoint. |
| 2021-06-15 | AstraZeneca | Results Update on AZD7442 STORM CHASER trial in post-exposure prevention of symptomatic COVID-19 astrazeneca.com ↗
The trial did not meet the primary endpoint of post-exposure prevention of symptomatic COVID-19 with AZD7442 compared to placebo. |
All press releases naming this drug 20 releases
Evidence & citations 4 cited values
Every value below carries the sentence it was read from. 4 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | AZD7442 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04625972 ↗ |
| Known as | Tixagevimab/Cilgavimab | “Efficacy, Safety, and Pharmacokinetics of AZD7442 (Tixagevimab/Cilgavimab) for Prevention of Symptomatic COVID-19: 15-Month Final Analysis of the PROVENT and STORM CHASER Trials.” PMID 38703336 ↗ May 2024 |
| Modality | Monoclonal antibody | “AZD7442, a combination product of two monoclonal antibodies (AZD8895 and AZD1061)” NCT04625972 ↗ |
| Route | Intramuscular | “Single dose (× 2 IM injections) of 300 mg of AZD7442 on Day 1.” NCT04625972 ↗ |