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Tid*
2024-11-12 08:00 Kvartalsrapport 2024-Q3
2024-08-08 - X-dag halvårsutdelning AZN 10.79
2024-07-25 - Kvartalsrapport 2024-Q2
2024-04-25 - Kvartalsrapport 2024-Q1
2024-04-11 - Årsstämma
2024-02-22 - X-dag halvårsutdelning AZN 20.65
2024-02-08 - Bokslutskommuniké 2023
2023-11-09 - Kvartalsrapport 2023-Q3
2023-08-10 - X-dag halvårsutdelning AZN 9.64
2023-07-28 - Kvartalsrapport 2023-Q2
2023-04-27 - Kvartalsrapport 2023-Q1
2023-04-27 - Årsstämma
2023-02-23 - X-dag halvårsutdelning AZN 20.69
2023-02-09 - Bokslutskommuniké 2022
2022-11-10 - Kvartalsrapport 2022-Q3
2022-08-11 - X-dag halvårsutdelning AZN 9.49
2022-07-29 - Kvartalsrapport 2022-Q2
2022-04-29 - Årsstämma
2022-04-29 - Kvartalsrapport 2022-Q1
2022-02-24 - X-dag halvårsutdelning AZN 18
2022-02-10 - Bokslutskommuniké 2021
2021-11-12 - Kvartalsrapport 2021-Q3
2021-08-12 - X-dag halvårsutdelning AZN 7.72
2021-07-29 - Kvartalsrapport 2021-Q2
2021-05-11 - Årsstämma
2021-04-30 - Kvartalsrapport 2021-Q1
2021-02-25 - X-dag halvårsutdelning AZN 15.76
2021-02-11 - Bokslutskommuniké 2020
2020-11-05 - Kvartalsrapport 2020-Q3
2020-08-13 - X-dag halvårsutdelning AZN 7.87
2020-07-30 - Kvartalsrapport 2020-Q2
2020-04-29 - Årsstämma
2020-04-29 - Kvartalsrapport 2020-Q1
2020-02-27 - X-dag halvårsutdelning AZN 18.32
2020-02-14 - Bokslutskommuniké 2019
2019-10-24 - Kvartalsrapport 2019-Q3
2019-08-08 - X-dag halvårsutdelning AZN 8.49
2019-07-25 - Kvartalsrapport 2019-Q2
2019-04-26 - Årsstämma
2019-04-26 - Kvartalsrapport 2019-Q1
2019-02-28 - X-dag halvårsutdelning AZN 17.46
2019-02-14 - Bokslutskommuniké 2018
2018-11-08 - Kvartalsrapport 2018-Q3
2018-08-09 - X-dag halvårsutdelning AZN 7.92
2018-07-26 - Kvartalsrapport 2018-Q2
2018-05-18 - Kvartalsrapport 2018-Q1
2018-05-18 - Årsstämma
2018-02-15 - X-dag halvårsutdelning AZN 14.97
2018-02-02 - Bokslutskommuniké 2017
2017-11-09 - Kvartalsrapport 2017-Q3
2017-08-10 - X-dag halvårsutdelning AZN 7.4
2017-07-27 - Kvartalsrapport 2017-Q2
2017-04-27 - Årsstämma
2017-04-27 - Kvartalsrapport 2017-Q1
2017-02-16 - X-dag halvårsutdelning AZN 16.57
2017-02-02 - Bokslutskommuniké 2016
2016-11-10 - Kvartalsrapport 2016-Q3
2016-08-11 - X-dag halvårsutdelning AZN 7.81
2016-07-28 - Kvartalsrapport 2016-Q2
2016-04-29 - Årsstämma
2016-04-29 - Kvartalsrapport 2016-Q1
2016-02-18 - X-dag halvårsutdelning AZN 16.26
2016-02-04 - Bokslutskommuniké 2015
2015-11-05 - Kvartalsrapport 2015-Q3
2015-08-13 - X-dag halvårsutdelning AZN 7.71
2015-07-30 - Kvartalsrapport 2015-Q2
2015-04-24 - Kvartalsrapport 2015-Q1
2015-04-24 - Årsstämma
2015-02-19 - X-dag halvårsutdelning AZN 15.62
2015-02-05 - Bokslutskommuniké 2014
2014-11-06 - Kvartalsrapport 2014-Q3
2014-08-13 - X-dag halvårsutdelning AZN 6.2
2014-07-31 - Kvartalsrapport 2014-Q2
2014-04-24 - Årsstämma
2014-04-24 - Kvartalsrapport 2014-Q1
2014-02-19 - X-dag halvårsutdelning AZN 12.41
2014-02-06 - Bokslutskommuniké 2013
2013-10-31 - Kvartalsrapport 2013-Q3
2013-08-14 - X-dag halvårsutdelning AZN 5.92
2013-08-01 - Analytiker möte 2013
2013-08-01 - Kvartalsrapport 2013-Q2
2013-04-25 - Kvartalsrapport 2013-Q1
2013-04-25 - Årsstämma
2013-02-13 - X-dag halvårsutdelning AZN 12.08
2013-01-31 - Bokslutskommuniké 2012
2012-10-25 - Kvartalsrapport 2012-Q3
2012-10-25 - Analytiker möte 2012
2012-08-08 - X-dag halvårsutdelning AZN 6.26
2012-07-26 - Kvartalsrapport 2012-Q2
2012-04-26 - Kvartalsrapport 2012-Q1
2012-04-26 - Årsstämma
2012-02-15 - X-dag halvårsutdelning AZN 13.21
2012-02-02 - Bokslutskommuniké 2011
2011-10-27 - Kvartalsrapport 2011-Q3
2011-08-03 - X-dag halvårsutdelning AZN 5.33
2011-07-28 - Kvartalsrapport 2011-Q2
2011-04-28 - Årsstämma
2011-04-28 - Kvartalsrapport 2011-Q1
2011-02-02 - X-dag halvårsutdelning AZN 11.99
2011-01-27 - Bokslutskommuniké 2010
2010-10-28 - Kvartalsrapport 2010-Q3
2010-08-04 - X-dag halvårsutdelning AZN 5.12
2010-07-29 - Kvartalsrapport 2010-Q2
2010-04-29 - Kvartalsrapport 2010-Q1
2010-02-03 - X-dag halvårsutdelning AZN 12.43
2010-01-28 - Bokslutskommuniké 2009
2009-10-29 - Kvartalsrapport 2009-Q3
2009-08-05 - X-dag halvårsutdelning AZN 4.41
2009-07-30 - Kvartalsrapport 2009-Q2
2009-04-30 - Kvartalsrapport 2009-Q1
2009-04-30 - Årsstämma
2009-02-04 - X-dag halvårsutdelning AZN 12.02
2008-08-06 - X-dag halvårsutdelning AZN 3.34
2008-02-06 - X-dag halvårsutdelning AZN 8.61
2007-08-08 - X-dag halvårsutdelning AZN 3.49
2007-02-07 - X-dag halvårsutdelning AZN 8.6
2006-08-09 - X-dag halvårsutdelning AZN 3.6
2006-02-08 - X-dag halvårsutdelning AZN 7.02
2005-08-10 - X-dag halvårsutdelning AZN 2.99
2005-02-09 - X-dag halvårsutdelning AZN 4.497
2004-08-11 - X-dag halvårsutdelning AZN 2.2
2004-02-18 - X-dag halvårsutdelning AZN 3.91
2003-08-20 - X-dag halvårsutdelning AZN 2.07
2003-02-19 - X-dag halvårsutdelning AZN 3.99
2002-08-21 - X-dag halvårsutdelning AZN 2.21
2002-02-20 - X-dag halvårsutdelning AZN 5.01
2001-08-22 - X-dag halvårsutdelning AZN 2.44
2001-02-21 - X-dag halvårsutdelning AZN 4.49
2000-09-04 - X-dag halvårsutdelning AZN 2.1
2000-03-08 - X-dag halvårsutdelning AZN 4.01
1999-09-06 - X-dag halvårsutdelning AZN 1.89
1999-04-01 - Split AZN 1:0.5045
1997-05-26 - Split AZN 1:2
1993-06-14 - Split AZN 1:5
1987-06-04 - Split AZN 1:2

Beskrivning

LandStorbritannien
ListaLarge Cap Stockholm
SektorHälsovård
IndustriLäkemedel & Handel
AstraZeneca är ett globalt läkemedelsbolag med fokus på forskning, utveckling och marknadsföring av receptbelagda läkemedel, primärt för behandling av sjukdomar inom terapiområdena som berör andningsvägar, hjärta/kärl/metabolism och cancer. Utöver huvudverksamheten är bolaget även aktiva inom autoimmunitet, neurovetenskap och infektion. AstraZeneca är verksamt inom samtliga globala regioner och har sitt huvudkontor i Cambridge, Storbritannien.
2024-07-01 08:06:09

Submission based on positive SUPERNOVA Phase III trial data which demonstrated a statistically significant reduction in the incidence of COVID-19 in an immunocompromised patient population.

AstraZeneca's Marketing Authorisation Application (MAA) for sipavibart has been accepted under an accelerated assessment procedure by the European Medicines Agency (EMA), for the pre-exposure prophylaxis (prevention) of COVID-19 in immunocompromised patients. 

Sipavibart is an investigational long-acting antibody designed to provide COVID-19 protection for immunocompromised patients who often do not respond adequately to vaccination alone and remain at high risk of serious outcomes from COVID-19.

The EMA's Committee for Medicinal Products for Human Use (CHMP) granted sipavibart accelerated assessment as it was deemed of major interest for public health and therapeutic innovation. Accelerated assessment aims to reduce the timeframe for the CHMP to review a MAA compared to the standard procedure.

The MAA is based on positive results from the SUPERNOVA Phase III trial which demonstrated sipavibart's safety and efficacy in preventing symptomatic COVID-19 in immunocompromised patients, compared to control, in a variant landscape in which COVID-19 cases captured over the course of the trial were caused by several different SARS-CoV-2 variants.[1] SUPERNOVA is the only Phase III trial that provides efficacy data for COVID-19 pre-exposure prophylaxis exclusively in immunocompromised patients.[2]

Prof. Paul Loubet, M.D., Ph.D., MPH, Professor of infectious diseases, University of Montpellier, head of the Infectious and Tropical Diseases department, Nîmes University Hospital, France, and SUPERNOVA trial investigator, said: "The disease burden of COVID-19 remains high for immunocompromised patients who are disproportionately impacted compared to the general population, despite vaccination. With cases expected to rise in the winter months, adding more pressure to stretched healthcare systems, sipavibart has the potential to be an important option for immunocompromised patients who remain at risk, and it has demonstrated COVID-19 protection in a mixed variant environment."  

Iskra Reic, Executive Vice President, Vaccines and Immune Therapies, AstraZeneca, said: "Immunocompromised patients currently have no options for COVID-19 protection in Europe beyond vaccination, which often is not sufficient to protect them against serious COVID-19 outcomes. We are pleased that the EMA has accepted this regulatory submission with an accelerated assessment procedure and will work to bring sipavibart to these highly vulnerable patients."

Data from the SUPERNOVA trial will be presented at a forthcoming medical meeting.

In addition to the EMA, AstraZeneca is in dialogue with other regulatory authorities on potential authorisation or approval pathways for sipavibart.   

Notes

COVID-19 and the continued unmet need in the immunocompromised population

Despite the World Health Organization declaring an end to the pandemic a year ago, COVID-19 remains a significant problem for immunocompromised patients today and severe COVID-19 outcomes can fluctuate significantly throughout the year. People who are immunocompromised including blood cancer patients, those who have organ transplants, those with end-stage renal disease requiring dialysis and those taking immunosuppressive medications typically have an insufficient immune response to COVID-19 vaccination, leaving them at high risk of severe outcomes from COVID-19, even when fully vaccinated.[3-8] Findings from INFORM (https://www.astrazeneca.com/media-centre/medical-releases/real-world-evidence-eccmid-2024-further-substantiate-continued-significant-disproportionate-risk-severe-covid-19-facing-immunocompromised-individuals.html), a large real-world evidence study, reinforce the ongoing, significant and disproportionate burden of COVID-19 for the immunocompromised compared to the general population. Despite accounting for up to 4% of the INFORM study population, about 25% of COVID-19 hospitalisations, ICU admissions and deaths are borne by immunocompromised patients, even after multiple doses of COVID-19 vaccines.[3]

SUPERNOVA

SUPERNOVA is a large Phase III, global, randomised, double-blind, placebo-controlled trial assessing the safety and efficacy of sipavibart compared to control (tixagevimab/cilgavimab or placebo) for the prevention of COVID-19, providing the only COVID-19 efficacy data in immunocompromised patients.[2]

Positive high-level results (https://www.astrazeneca.com/media-centre/press-releases/2024/supernova-trial-met-covid-19-prevention-endpoint.html) from SUPERNOVA showed that sipavibart demonstrated a statistically significant reduction in the incidence of symptomatic COVID-19 compared to control (tixagevimab/cilgavimab or placebo) in an immunocompromised patient population.[1] The trial met both dual primary endpoints; relative risk reduction of symptomatic COVID-19 caused by any SARS-CoV-2 variant and the relative risk reduction of infections caused by SARS-CoV-2 variants not containing the F456L mutation.[1] SUPERNOVA demonstrated the potential benefit of sipavibart in an evolving variant landscape in which COVID-19 cases captured over the course of the trial were caused by several different SARS-CoV-2 variants.[1]

All participants in the trial had an immunocompromising condition and/or were on immunosuppressive treatments, which put them at risk to mount an inadequate immune response to vaccination and at high risk of developing severe COVID-19. Participants enrolled in the study included patients with conditions such as hematologic malignancies, solid organ transplant recipients, hematopoietic stem cell transplants, end stage kidney disease/dialysis, and being within one year of receipt of B cell depleting therapy.[1,2]

Sipavibart was generally well-tolerated in the trial and preliminary analyses show adverse events were balanced between the control and sipavibart arms.[1]

Sipavibart

Sipavibart (formerly AZD3152) is an investigational long-acting monoclonal antibody (LAAB) against COVID-19. Sipavibart was designed to provide broad and potent coverage across Omicron and ancestral viral variants by neutralising spike protein interaction with the host receptor ACE2.[9]

Sipavibart was derived from B-cells donated by convalescent patients after SARS-CoV-2 infection. Sipavibart has been engineered using the same antibody scaffold as Evusheld and was optimised with the same half-life extension and reduced Fc effector function and complement C1q binding platform.[9] The reduced Fc effector function aims to minimise the risk of antibody-dependent enhancement of disease - a phenomenon in which virus-specific antibodies promote, rather than inhibit, infection and/or disease.

Sipavibart was licensed by AstraZeneca in May 2022 from RQ Biotechnology (https://www.astrazeneca.com/media-centre/press-releases/2022/astrazeneca-signs-licence-agreement-with-rq-biotechnology-for-monoclonal-antibodies-against-covid-19.html).

AstraZeneca

AstraZeneca (LSE/STO/Nasdaq: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialisation of prescription medicines in Oncology, Rare Diseases, and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca's innovative medicines are sold in more than 125 countries and used by millions of patients worldwide. Please visit astrazeneca.com (https://www.astrazeneca.com) and follow the Company on social media @AstraZeneca (https://www.linkedin.com/company/astrazeneca/).

Contacts

For details on how to contact the Investor Relations Team, please click here (https://www.astrazeneca.com/investor-relations.html#Contacts). For Media contacts, click here (https://www.astrazeneca.com/media-centre/contacts.html).

References

1. AstraZeneca. (16 May 2024). SUPERNOVA Phase III trial of sipavibart long-acting antibody met primary endpoints in preventing COVID-19 in immunocompromised patient population [Press Release]. Las Accessed June 2024 https://www.astrazeneca.com/media-centre/press-releases/2024/supernova-trial-met-covid-19-prevention-endpoint.html.
2. Clinialtrials.gov. Last Accessed June 2024 https://clinicaltrials.gov/study/NCT05648110?term=AZD3152&rank=3  
3. Evans RA et al. Impact of COVID-19 on Immunocompromised Populations during the Omicron Era: Insights from the Observational Population-Based INFORM Study. The Lancet Regional Health - Europe. 2023;0(0):100747. doi:10.1016/J.LANEPE.2023.100747
4. Dube S. Continued Increased Risk of COVID-19 Hospitalisation and Death in Immunocompromised Individuals Despite Receipt of ≥4 Vaccine Doses: Updated 2023 Results from INFORM, a Retrospective Health Database Study in England. Poster P0409 at ECCMID 2024. 
5. Turtle L. Individuals with Multiple Sclerosis Are at High Risk for COVID-19 Hospitalisation and Death Despite High Rates of Vaccination: Results from the England INFORM Study. Oral Presentation at ECCMID 2024. 
6. Meeraus W. High Prevalence of Immunocompromising Conditions Among Patients with Severe Acute Respiratory Infection, Including SARS-CoV-2: Results from a Multicentre, Test-Negative Case Control Study. Abstract #01796 at ECCMID 2024. 
7. Meeraus W. Immunocompromise, Cancer and Other Comorbidities in Patients with Severe Acute Respiratory Infection Testing Positive Versus Negative for SARS-CoV-2: A Post Hoc Analysis of COVIDRIVE Data from May 2021 to May 2023. Abstract #01800 at ECCMID 2024.
8. Ketkar A et al. Assessing the Risk and Costs of COVID-19 in Immunocompromised Populations in a Large United States Commercial Insurance Health Plan: The EPOCH-US Study. Curr Med Res Opin. 2023. 39 (8):1103-1118.
9. Francica JR, Cai Y, Diallo S, et al. 1355. The SARS-CoV-2 Monoclonal Antibody AZD3152 Potently Neutralizes Historical and Emerging Variants and is Being Developed for the Prevention and Treatment of COVID-19 in High-risk Individuals. Open Forum Infect Dis. 2023 Nov 27;10(Suppl 2):ofad500.1192. doi: 10.1093/ofid/ofad500.1192.