AstraZeneca and its global biologics research and development arm, MedImmune, today announced that the US Food and Drug Administration (FDA) has approved Fasenra (benralizumab) for the add-on maintenance treatment of patients with severe asthma aged 12 years and older, and with an eosinophilic phenotype.
Benralizumab riktar sig mot och avlägsnar snabbt eosinofiler och är det första biologiska läkemedlet för sjukdomar i andningsvägarna med en 8-veckorsdosering för underhållsbehandling
Rekommendationen är baserad på omfattande fas III-program som uppvisar betydande minskningar av astmaanfall, förbättrad lungfunktionoch minskad användning av orala steroider
AstraZeneca och MedImmune, bolagets g
Pascal Soriot, koncernchef, kommenterar resultatet:
”Våra ekonomiska resultat under kvartalet ligger i linje med förväntningarna och återspeglar bra genomförande på marknadssidan, inklusive stark tillväxt på tillväxtmarknaderna med enastående försäljning i Kina.
Det mest anmärkninsvärda är dock mängden nyheter och godkännanden. I synnerhet kompenserade den positiva utvecklingen för Tagrisso
AstraZeneca and MedImmune, its global biologics research and development arm, will be underlining its scientific focus on cardiovascular, renal and metabolic diseases (CVMD) with 28 presentations, including two late-breaking trials, at the American Heart Association (AHA) Scientific Sessions, November 11-15, 2017 in Anaheim, California.
AstraZeneca and its global biologics research and development arm, MedImmune, today announced the top-line results of the Phase III STRATOS 2 and TROPOS trials for tralokinumab, an anti-interleukin-13 (IL-13) human monoclonal antibody, in severe, uncontrolled asthma.
In STRATOS 2, tralokinumab did not achieve a statistically-significant reduction in the annual asthma exacerbation rate (AA
AstraZeneca och dess FoU-center för hematologi, Acerta Pharma, meddelar idag att den amerikanska läkemedelsmyndigheten FDA har godkänt Calquence(acalabrutinib) inom ramen för så kallat ”påskyndat godkännande” Calquence är en tyrosinkinashämmare och indikationen gäller behandling av vuxna patienter med mantelcellslymfom (MCL) som har fått minst en tidigare behandling. 1
AstraZeneca and MedImmune, its global biologics research and development arm, today announced the expansion of their clinical collaboration with Incyte Corporation.
AstraZeneca and Merck & Co., Inc., Kenilworth, NJ, US today announced that they have submitted a new drug application (NDA) to Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) for the use of Lynparza(olaparib) tablets in unresectable or recurrent BRCA-mutated breast cancer, with a decision expected in the second half of 2018.
AstraZeneca today announced that the US Food and Drug Administration (FDA) has approved Bydureon BCise (exenatide extended-release) injectable suspension, a new formulation of Bydureon in an improved once-weekly, single-dose autoinjector device for adults with type-2 diabetes whose blood sugar remains uncontrolled on one or more oral medicines in addition to diet and exercise
Lynparza has the potential to offer a new treatment option for patients with germline BRCA-mutated, HER2-negative metastatic breast cancer Regulatory submission acceptance is first for a PARP inhibitor beyond ovarian cancer
Imfinzi granted Priority Review Acceptance follows FDA’s Breakthrough Therapy Designation
Early-stage disease - Quality-of-life results from the Imfinzi Phase III PACIFIC trial headline the Presidential Symposium Overcoming treatment resistance - Novel combination of Tagrisso and savolitinib provide potential new options for EGFRm patients with MET resistance
AstraZeneca, along with MedImmune, its global biologics research and development arm, has announced that the European Medicines Agency (EMA) has accepted a Marketing Authorisation Application (MAA) for Imfinzi (durvalumab) for the treatment of patients with locally-advanced (Stage III), unresectable non-small cell lung cancer
AstraZeneca today announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for Tagrisso (osimertinib) for the 1st-line treatment of patients with metastatic epidermal growth factor receptor (EGFR) mutation-positive non-small cell lung cancer (NSCLC).
Tandvårds- och läkemedelsförmånsverket, TLV, har beslutat att AstraZenecas läkemedel Tagrisso® (osimertinib) från och med den 1 oktober ingår i läkemedelsförmånerna för vuxna patienter med lokalt avancerad eller metastaserad epidermal tillväxtfaktorreceptor (EGFR) T790M mutationspositiv icke-småcellig lungcancer (NSCLC).
hase III, PINNACLE 4 trial demonstrates positive top-line results compared to its monotherapy components and placebo Trial supports filing of new drug applications in Japan and China
Largest and most inclusive patient population of any GLP-1 CV outcomes trial with 14,500 patients at 687 trial sites across 35 countries Full trial results presented at the annual meeting of the European Association for the Study of Diabetes (EASD) and simultaneously published in the New England Journal of Medicine
Agreement builds on 2016 collaboration on commercialisation rights to anaesthetic medicines in markets outside the US
Further analysis of the Phase III trials, SIROCCO and CALIMA, reinforces benralizumab’s efficacy and identifies more frequent prior exacerbations and/or greater baseline blood eosinophil count as key predictors of an enhanced treatment effect. Findings pave the way for a personalised treatment approach to guide more precise selection of the benralizumab-responsive patient.
Phase III FLAURA trial results show Tagrisso reduced the risk of progression or death by more than half, with consistent benefit across all subgroups, including patients with and without brain metastases
Unprecedented median progression-free survival (PFS) of 18.9 months compared with 10.2 months for the current standard of care
Clinically-meaningful preliminary overall survival benefit
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