First sub-analyses from the DECLARE-TIMI 58 trial further support the cardiovascular effects of Farxiga in type-2 diabetes

Pressmeddelanden   •   Mar 18, 2019 14:03 CET

Positive results from a pre-specified sub-analysis of the Phase III DECLARE-TIMI 58 trial showed that Farxiga (dapagliflozin) reduced the relative risk of major adverse cardiovascular events (MACE) by 16% compared to placebo in patients with type-2 diabetes (T2D) who had a prior heart attack (myocardial infarction).

US FDA grants saracatinib Orphan Drug Designation for idiopathic pulmonary fibrosis

Pressmeddelanden   •   Mar 18, 2019 08:01 CET

The US Food and Drug Administration has granted Orphan Drug Designation for saracatinib, a potential new medicine for the treatment of IPF, a type of lung disease that results in scarring (fibrosis) of the lungs. Saracatinib is an inhibitor of src kinase which regulates broad cell functions including cell growth and cell differentiation.1 Saracatinib has completed Phase I development.

AstraZeneca showcases next-generation Oncology pipeline addressing unmet patient needs at AACR Annual Meeting

Pressmeddelanden   •   Mar 14, 2019 08:03 CET

AstraZeneca will share pioneering research and development across its successful Oncology portfolio and extensive next-generation pipeline at the American Association for Cancer Research (AACR) Annual Meeting in Atlanta, USA, 29 March to 3 April 2019.

AstraZeneca to present new cardiovascular data on Farxiga in type-2 diabetes at ACC 2019

Pressmeddelanden   •   Mar 11, 2019 08:03 CET

First sub-analyses from Phase III DECLARE-TIMI 58 trial selected for late-breaking clinical trial and oral presentations. Data evaluating the CV effects of Farxiga, including hospitalisation for heart failure in adults with type-2 diabetes have been selected for late-breaking clinical trial and oral presentations at the American College of Cardiology’s on 16-18 March.

Lynparza receives positive EU CHMP opinion for use in germline BRCA-mutated HER2-negative advanced breast cancer

Pressmeddelanden   •   Mar 01, 2019 14:48 CET

AstraZeneca and MSD, Inc. today announced that the CHMP of the European Medicines Agency has adopted a positive opinion, recommending the use of Lynparza (olaparib) tablets as monotherapy for the treatment of adult patients with germline BRCA1/2-mutations, who have human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer.

Lynparza significantly delayed disease progression as 1st-line maintenance treatment in germline BRCA-mutated metastatic pancreatic cancer

Pressmeddelanden   •   Feb 26, 2019 08:03 CET

AstraZeneca and MSD Inc., Kenilworth, N.J., US (MSD: known as Merck & Co., Inc. inside the US and Canada) today announced positive results from the Phase III POLO trial. Results from the trial showed a statistically-significant and clinically-meaningful improvement in progression-free survival (PFS) with Lynparza (olaparib) vs. placebo.

Brilinta’s Phase III THEMIS trial met primary endpoint in patients with established coronary artery disease and type-2 diabetes

Pressmeddelanden   •   Feb 25, 2019 08:03 CET

The Phase III THEMIS trial met its primary endpoint and demonstrated that Brilinta (ticagrelor), taken in conjunction with aspirin, showed a statistically-significant reduction in a composite of major adverse cardiovascular events (MACE) compared to aspirin alone.

AstraZeneca PLC:s resultatrapport för helåret och fjärde kvartalet 2018

Pressmeddelanden   •   Feb 14, 2019 08:04 CET

Nya lanseringar och det kommersiella genomförandet ger en tillväxt i produktförsäljningen för helåret och ett mycket starkt sista kvartal. 2019 förväntas bli ett år med högre tillväxt i produktförsäljningen jämfört med föregående år, kombinerat med en operativ hävstångseffekt.

US FDA grants Fasenra Orphan Drug Designation for hypereosinophilic syndrome

Pressmeddelanden   •   Feb 06, 2019 08:02 CET

The US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to Fasenra (benralizumab) for the treatment of hypereosinophilic syndrome (HES). HES is a group of rare, potentially fatal disorders characterised by high numbers of eosinophils in blood and tissues, which can cause progressive damage to any organ in the body.

US FDA grants Breakthrough Therapy Designation for potential next-generation RSV medicine MEDI8897

Pressmeddelanden   •   Feb 05, 2019 08:10 CET

Designation based on positive primary analysis of the Phase IIb trial that demonstrated the safety and efficacy of MEDI8897

AstraZeneca and its global biologics research and development arm, MedImmune, today announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for MEDI8897, an extended half-life respiratory syncytial virus (RSV) F monoclonal antibody (mAb) being developed for the prevention of lower respiratory tract infection (LRTI) caused by RSV.

A BTD is designed to expedite the development and regulatory review of medicines that are intended to treat a serious condition and that have shown encouraging early clinical results, which may demonstrate substantial improvement on a clinically-significant endpoint over available medicines. MEDI8897 is being developed in partnership with Sanofi Pasteur and received Fast Track designation from the US FDA in March 2015.

Mene Pangalos, Executive Vice-President, R&D BioPharmaceuticals, said: “MEDI8897 is our next-generation preventive medicine for respiratory syncytial virus, which has the potential to address an important unmet need for infants, families and caregivers. The Breakthrough Therapy Designation, together with its recent PRIME eligibility from the European Medicines Agency, will help us to bring MEDI8897 to all infants at risk for RSV as quickly as possible.”

The BTD is based on the primary analysis of the Phase IIb trial to evaluate the safety and efficacy of MEDI8897, which met its primary endpoint defined as a statistically-significant reduction in the incidence of medically-attended LRTI caused by reverse transcriptase polymerase chain reaction-confirmed RSV, for 150 days after dosing in healthy preterm infants. Full results from the Phase IIb trial will be presented at a forthcoming medical meeting.

About MEDI8897

MEDI8897 is an extended half-life RSV F mAb being developed for the prevention of LRTI caused by RSV. MEDI8897 is being developed for use in a broader infant population than the current standard of care for RSV prevention, Synagis (palivizumab), which in the US is only approved for use in high-risk infants. Additionally, MEDI8897 is being developed so that it may only require one dose during a typical five-month RSV season, vs. monthly injections with current standard of care.1

The development programme for MEDI8897 also includes a Phase III trial in late preterm and healthy full-term infants. AstraZeneca will also conduct a Phase II/III study in Synagis-eligible paediatric patients to generate additional data for use in this population.

In February 2019, the EMA granted PRIME eligibility to MEDI8897.

In March 2017, AstraZeneca and Sanofi Pasteur announced an agreement to develop and commercialise MEDI8897 jointly. In November 2018, AstraZeneca announced Swedish Orphan Biovitrum AB (publ) (Sobi) has the right to participate in payments that may be received from the US profits or losses for MEDI8897.

About RSV

RSV is the most common cause of LRTI in infants and young children worldwide, and 90% of children are infected with RSV in the first two years of life. Of those, up to 40% will experience a LRTI with the initial episode, making the development and availability of effective prevention methods a critical public health priority.2 In the US, there is currently one approved medicine for RSV prophylaxis, Synagis (palivizumab), indicated for high-risk children (premature infants ≤ 35 weeks gestational age, children with chronic lung disease of prematurity, and children with haemodynamically significant chronic heart disease).3

About MedImmune

MedImmune is the global biologics research and development arm of AstraZeneca, a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialisation of small molecule and biologic prescription medicines. MedImmune is pioneering innovative research and exploring novel pathways across Oncology, Respiratory, Cardiovascular, Renal and Metabolic Diseases, and Infection and Vaccines. The MedImmune headquarters is located in Gaithersburg, Md., one of AstraZeneca’s three global R&D centres, with additional sites in Cambridge, UK and South San Francisco, CA. For more information, please visit www.medimmune.com.

About AstraZeneca

AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in three therapy areas - Oncology, Cardiovascular, Renal & Metabolism and Respiratory. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information, please visit astrazeneca.comand follow us on Twitter @AstraZeneca.

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References

1.Domachowske JB, Khan AA, Esser MT, et al. Safety, Tolerability, and Pharmacokinetics of MEDI8897, an Extended Half-Life Single-Dose Respiratory Syncytial Virus Prefusion F-Targeting Monoclonal Antibody Administered as a Single Dose to Healthy Preterm Infants. The Pediatric Infectious Disease Journal. September 2018:886-892. doi:10.1097/inf.0000000000001916.

2.Adamko DJ, Friesen M. Why does respiratory syncytial virus appear to cause asthma? Journal of Allergy and Clinical Immunology. 2012;130(1):101-102. doi:10.1016/j.jaci.2012.05.024.

3.Synagis Prescribing Information.

Om AstraZeneca

AstraZeneca är ett globalt, innovationsdrivet bioläkemedelsföretag med fokus på forskning, utveckling och marknadsföring av receptbelagda läkemedel, primärt för behandling av sjukdomar inom tre huvudsakliga terapiområden: cancer, kardiovaskulära sjukdomar, njursjukdomar och metabola sjukdomar och sjukdomar i andningsvägarna. Bolaget är också selektivt aktivt inom autoimmunitet, neurovetenskap och infektion. AstraZeneca bedriver verksamhet i över 100 länder och dess innovativa läkemedel används av miljontals patienter över hela världen.

Mer information finns på: www.astrazeneca.com och www.astrazeneca.se. Du kan även följa oss på twitter https://twitter.com/AstraZenecaSE

AstraZeneca and its global biologics research and development arm, MedImmune, today announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for MEDI8897, an extended half-life respiratory syncytial virus (RSV) F monoclonal antibody (mAb) being developed for the prevention of lower respiratory tract infection (LRTI) caused by RSV.

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Om AstraZeneca

Om AstraZeneca

AstraZeneca är ett globalt, innovationsdrivet bioläkemedelsföretag med fokus på forskning, utveckling och marknadsföring av receptbelagda läkemedel, primärt för behandling av sjukdomar inom tre huvudsakliga terapiområden: cancer, kardiovaskulära sjukdomar, njursjukdomar och metabola sjukdomar och sjukdomar i andningsvägarna. Bolaget är också selektivt aktivt inom autoimmunitet, neurovetenskap och infektion. AstraZeneca bedriver verksamhet i över 100 länder och dess innovativa läkemedel används av miljontals patienter över hela världen. Mer information finns på: www.astrazeneca.com och www.astrazeneca.se