Working with the UK government, first vaccinations to begin early in the New Year
Regulatory interactions continue around the world for next approvals
AstraZeneca’s COVID-19 vaccine has been approved for emergency supply in the UK, with the first doses being released today so that vaccinations may begin early in the New Year.
The UK Medicines and Healthcare products Regulatory Agency (MHR
AstraZeneca and MSD’s Lynparza (olaparib) has been approved in Japan for the treatment of advanced ovarian, prostate and pancreatic cancers.
AstraZeneca and Amgen today announced high-level results from the SOURCE Phase III trial which assessed the efficacy and safety of the potential new medicine tezepelumab compared to placeboin 150 severe asthma patients who required maintenance use of oral corticosteroids (OCS) on top of standard of care (SoC).
AstraZeneca’s Tagrisso (osimertinib) has been approved in the US for the adjuvant treatment of adult patients with early-stage epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) after tumour resection with curative intent. Tagrisso is indicated for EGFRm patients whose tumours have exon 19 deletions or exon 21 L858R mutations as detected by an approved test.
The US Food and Drug Administration (FDA) has requested further clarifying analyses of clinical data, to complete its review of the New Drug Application (NDA) for roxadustat, an oral hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor for patients with anaemia of chronic kidney disease (CKD).
AstraZeneca's Imfinzi has been recommended for marketing authorisation in the EU for an additional dosing option, 1,500mg fixed dose every four weeks, in the approved indication of locally advanced, unresectable non-small cell lung cancer (NSCLC) in adults whose tumours express PD-L1 on at least 1% of tumour cells and whose disease has not progressed following platinu-based chemoradiation therapy.
Recommendation based on positive results from the DESTINY-Breast01 trial, which showed durable responses in patients with previously treated disease
AstraZeneca and Daiichi Sankyo Company, Limited (Daiichi Sankyo)’s trastuzumab deruxtecan has been recommended for conditional marketing authorisation in the European Union (EU) as a monotherapy for the treatment of adult patients with unresectable
Fourth major approval for AstraZeneca’s triple-combination therapy which is marketed as Breztri Aerosphere in the US, China and Japan
AstraZeneca’s Trixeo Aerosphere (formoterol fumarate/glycopyrronium bromide/budesonide) has been approved in the European Union (EU) for maintenance treatment in adult patients with moderate to severe chronic obstructive pulmonary disease (COPD) who are not adequ
AstraZeneca and Alexion Pharmaceuticals, Inc. (Alexion) have entered into a definitive agreement for AstraZeneca to acquire Alexion.
Updated results from the positive DESTINY-Breast01 Phase II trial showed AstraZeneca and Daiichi Sankyo Company, Limited (Daiichi Sankyo)’s Enhertu (trastuzumab deruxtecan) continued to demonstrate impressive efficacy and durable responses in patients with HER2-positive metastatic breast cancer following two or more prior HER2-based regimens.
Results of an interim analysis of the Phase III programme conducted by Oxford University with AZD1222, peer-reviewed and published in The Lancet today, demonstrated that the vaccine is safe and effective at preventing symptomatic COVID-19 and that it protects against severe disease and hospitalisation.
A pooled analysis of cardiovascular (CV) safety data from 762 patients treated with Calquence (acalabrutinib) monotherapy for chronic lymphocytic leukaemia (CLL), the most common type of adult leukaemia, across four clinical trials showed a low incidence of cardiac adverse events (AEs) leading to discontinuation.
Long-term follow-up results from the positive ACE-LY-004 Phase II trial showed patients with relapsed or refractory mantle cell lymphoma (MCL) treated with Calquence (acalabrutinib) remained progression free for a median of 22 months, with median overall survival not yet reached at three years of follow-up. The safety and tolerability profile remained consistent.
AstraZeneca will unveil new developments across a range of stages and subtypes of breast cancer at the 2020 San Antonio Breast Cancer Symposium (SABCS), which will be held virtually from 8 to 11 December 2020.
AstraZeneca has agreed to sell the rights to Crestor(rosuvastatin) and associated medicines in over 30 countries in Europe, except the UK and Spain, to Grünenthal GmbH (Grünenthal). Crestor is a statin approved for the treatment of dyslipidaemia and hypercholesterolaemia.
AstraZeneca’s Forxiga (dapagliflozin) has been approved in Japan for the treatment of patients with chronic heart failure (HF) who are receiving standard of care.
Two different dosing regimens demonstrated efficacy with one showing a better profile. No hospitalisations or severe cases of COVID-19 in participants treated with AZD1222.
Four-week dosing now approved in all Imfinzi indications, reducing medical visits and improving patient convenience.
AstraZeneca will present new research aimed at addressing key unmet needs facing patients with blood cancers at the 62nd American Society of Hematology (ASH) Annual Meeting and Exposition, held virtually from 5 to 8 December 2020.
The CALAVI Phase II trials for Calquence (acalabrutinib) in patients hospitalised with respiratory symptoms of COVID-19 did not meet the primary efficacy endpoint. The addition of Calquence to best supportive care (BSC) did not increase the proportion of patients who remained alive and free of respiratory failure. No new safety signal for Calquence was observed in the trials.