AstraZeneca today announced that the US Food and Drug Administration has granted Orphan Drug Designation for Fasenra (benralizumab) for the treatment of Eosinophilic Granulomatosis with Polyangiitis (EGPA).
AstraZeneca has entered into an agreement with Covis Pharma B.V. (Covis Pharma) to sell its rights to the medicines Alvesco (ciclesonide), usedfor the treatment of persistent asthma, and Omnaris and Zetonna (ciclesonide), used for the treatment of nasal symptoms associated with rhinitis. The rights cover markets outside the US and the US royalties for the medicines.
AstraZeneca today announced that the CHMP of the European Medicines Agency has adopted a positive opinion, recommending the marketing authorisation for Bevespi Aerosphere (glycopyrronium/formoterol fumarate) in a pressurised metered-dose inhaler (pMDI) as a maintenance dual bronchodilator treatment to relieve symptoms inadult patients with chronic obstructive pulmonary disease (COPD).
AstraZeneca and MedImmune, today announced that new data from the BORA Phase III extension trial of Fasenra (benralizumab) is among 43 company abstracts accepted for oral and poster presentation at the European Respiratory Society (ERS) International Congress 2018, 15-19 September in Paris.
AstraZeneca and its partner Amgen Inc. (Amgen) today announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for tezepelumab in patients with severe asthma, without an eosinophilic phenotype, who are receiving inhaled corticosteroids/long-acting beta2-agonists with or without oral corticosteroids and additional asthma controllers.
TERRANOVA trial did not meet the primary endpoint of a statistically-significant reduction of exacerbations in patients with chronic obstructive pulmonary disease
AstraZeneca today announced results from the Phase III SYGMA trials of Symbicort Turbuhaler (budesonide/formoterol) given as an anti-inflammatory reliever ‘as needed’ versus two different treatment regimens in patients with mild asthma.
AstraZeneca and MedImmune, its global biologics research and development arm, will present updates from its respiratory medicines and pipeline at the ATS 2018 International Congress, 18-23 May in San Diego, US. The breadth and depth of science are reflected in the 60 accepted abstracts, including five oral presentations, which focus on key areas of unmet need in asthma and COPD.
Inför Världsastmadagen 1 maj: I PACEHR-studien har fler än 18,500 astmapatienter i Sverige studerats. Majoriteten hade en lindrig och medelsvår astma och 790 personer hade svår astma. Data från 36 vårdcentraler runt om i Sverige jämfördes med uppgifter från hälsoregister under åren 2006-2013. Syftet med studien var att beskriva förekomst, samsjuklighet, dödlighet och behandling av svår astma.
AstraZeneca today announced top-line results from the Phase III KRONOS trial that showed PT010 (budesonide/glycopyrronium/formoterol fumarate 320/14.4/9.6µg, using Aerosphere Delivery Technology, in a pressurised metered-dose inhaler or pMDI) demonstrated a statistically significant improvement compared with dual combination therapies in six out of seven lung function primary endpoints.
AstraZeneca and its global biologics research and development arm, MedImmune, today announced that the European Commission (EC) has approved Fasenra (benralizumab) as an add-on maintenance treatment in adult patients with severe eosinophilic asthma inadequately controlled despite high-dose inhaled corticosteroids plus long-acting beta-agonists.
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, bolage
