AstraZeneca presents results from the positive Phase III TULIP 2 trial for anifrolumab

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AstraZeneca (LON:AZN) has presented detailed results from the positive Phase III TULIP 2 trial for anifrolumab, a potential new medicine for the treatment of moderate to severe systemic lupus erythematosus (SLE), which demonstrated superiority across multiple efficacy endpoints versus placebo, with both arms receiving standard of care. On the primary endpoint, anifrolumab achieved a statistically significant and clinically meaningful reduction in …

AstraZeneca PLC Roxadustat pooled analyses: no increased CV risk

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AstraZeneca (LON: AZN) and FibroGen Inc. have presented pooled efficacy and cardiovascular safety analyses from the pivotal Phase III programme assessing roxadustat for the treatment of patients with anaemia from chronic kidney disease. The pooled CV safety analyses showed that roxadustat, an oral first-in-class hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), did not increase the risk of MACE, MACE+ and all-cause …

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AstraZeneca presented results from Phase III OLYMPUS and ROCKIES trials

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AstraZeneca (LON:AZN) has presented detailed results from the Phase III OLYMPUS and ROCKIES trials showing that roxadustat significantly increased haemoglobin levels in non-dialysis-dependent and dialysis-dependent patients with anaemia from chronic kidney disease, respectively. The OLYMPUS trial compared roxadustat to placebo while the ROCKIES trial compared roxadustat to epoetin alfa. The results were presented today during two oral sessions at the …

AstraZeneca divests rights to Seroquel and Seroquel XR in Europe and Russia

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AstraZeneca (LON:AZN)has agreed the sale and licence of the commercial rights to Seroquel (quetiapine fumarate immediate release) and Seroquel XR (quetiapine fumarate extended release) in Europe and Russia to Cheplapharm Arzneimittel GmbH (Cheplapharm). Seroquel  and Seroquel XR, used primarily to treat schizophrenia and bipolar disorder, have lost their compound patent protection in Europe and Russia. Ruud Dobber, Executive Vice President, Biopharmaceuticals, said: “Seroquel is an important …

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AstraZeneca Patients to benefit from further pipeline progress

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AstraZeneca (LON:AZN) announced its year-to-date and Q3 2019 results. Year-to-date Product Sales growth of 13% (17% at CER1) to $17,315m included third-quarter Product Sales of $6,132m (+16%, +18% at CER). The third quarter again saw all three therapy areas and every sales region produce encouraging performances, including: –    The continued performance of new medicines2, with sales growth in the quarter of …

AstraZeneca Farxiga approved in the US by FDA

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AstraZeneca (LON:AZN) announced that the US Food and Drug Administration has approved Farxiga (dapagliflozin) to reduce the risk of hospitalisation for heart failure (hHF) in adults with type-2 diabetes  and established cardiovascular disease or multiple cardiovascular risk factors. The approval is based on results from the landmark DECLARE-TIMI 58 CV outcomes trial (CVOT), the largest sodium-glucose cotransporter 2 (SGLT2) inhibitor CVOT conducted to date to evaluate T2D …

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AstraZeneca Trastuzumab deruxtecan granted FDA Priority Review

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AstraZeneca (LON:AZN) and Daiichi Sankyo Company Limited announced that the US Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) for [fam-] trastuzumab deruxtecan (DS-8201) and granted Priority Review. The Prescription Drug User Fee Act (PDUFA) date for trastuzumab deruxtecan, a HER2-targeting antibody drug conjugate (ADC) and potential new medicine for the treatment of HER2-positive metastatic …

AstraZeneca PLC Fasenra approved in the US for self-administration

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Fasenra is now the only respiratory biologic that offers the choice of administration at home or in a doctor’s office with eight-week maintenance dosing AstraZeneca plc (LON: AZN) has today announced that the US Food and Drug Administration (FDA) has approved the self-administration of Fasenra (benralizumab) in a pre-filled, single-use auto-injector (the Fasenra Pen). The approval is supported by data …

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AstraZeneca sells Losec rights to Cheplapharm for $243 million

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AstraZeneca (LON: AZN) has agreed to sell the global commercial rights, excluding China, Japan, the US and Mexico, for Losec (omeprazole) and associated brands to Cheplapharm Arzneimittel GmbH (Cheplapharm). The divestment includes medicines containing omeprazole marketed by AstraZeneca or its collaborators under the Acimax, Antra, Mepral, Mopral, Omepral and Zoltum medicine names. Ruud Dobber, Executive Vice President, BioPharmaceuticals, said: “This …

AstraZeneca PLC Qtrilmet recommended for approval in EU by CHMP

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AstraZeneca (LON: AZN) has today announced that Qtrilmet (metformin hydrochloride, saxagliptin and dapagliflozin) modified-release tablets have been recommended for marketing authorisation in the European Union for the treatment of adults with type-2 diabetes (T2D). The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) based its positive opinion on data from five Phase III trials …