Bevespi Aerosphere har godkänts av FDA för patienter med KOL

Visar på tydlig förbättring i lungfunktion jämfört med monokomponenter och placebo

Den enda långtidsverkande dubbla luftrörsvidgaren som kommer i en dosaerosol (pMDI) och den första produkten med AstraZenecas patenterade Co-Suspension Technology

AstraZeneca meddelar idag att amerikanska Food and Drug Administration har godkänt Bevespi Aerosphere (glykopyrrolat och formoterolfumarat),en inhalationsaerosol avsedd för långverkande underhållsbehandling av luftvägsobstruktion hos patienter med kroniskt obstruktiv lungsjukdom (KOL) samt kronisk bronkit och/eller emfysem.

Sean Bohen, Executive Vice President, Global Medicines Development och Chief Medical Officer, säger: ”Tack vare godkännandet av Bevespi Aerospherekan vi nu ge patienter den första LAMA/LABA-kombinationen i en dosaerosol med vår nya unika beredningsteknik. LAMA/LABA-kombinationer blir allt vanligare som ett prioriterat behandlingsalternativ för många KOL-patienter. Denna läkemedelsklass syftar till att ge maximal luftrörsvidgning, vilket gör det möjligt för patienter att andas lättare och kan hjälpa dem att vara mer fysiskt aktiva.”

Bevespi Aerosphereär en dubbel luftrörsvidgare i fast kombination som tas två gånger dagligen och kombinerar glykopyrrolat, en långtidsverkande muskarinantagonist (LAMA), och formoterolfumarat, en långtidsverkande beta-2-agonist (LABA). FDA:s godkännande bygger på det kliniska prövningsprogrammet PINNACLE, som visade att Bevespi Aerosphere ledde till statistiskt signifikant förbättring av forcerad expiratorisk volym under första sekunden (FEV1) på morgonen före medicinering vid 24 veckor (p<0,001) jämfört med dess monokomponenter och placebo.

Bevespi Aerosphere är den första produkten som har godkänts med AstraZenecas Co-Suspension Technology. Denna teknik gör det möjligt att leverera en jämn dos av ett eller flera läkemedel från en och samma dosaerosol (pMDI). Tekniken tillämpas på en rad av AstraZenecas inhalerade kombinationsbehandlingar för andningsvägar som för närvarande är under klinisk utveckling, som till exempel den fasta trippelkombinationen av LAMA/LABA/Inhalerad kortikosteroid (PT010).

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NOTES TO EDITORS

About COPD

COPD (chronic obstructive pulmonary disease) is a progressive disease associated mainly with tobacco smoking, air pollution or occupational exposure, which can cause obstruction of airflow in the lungs resulting in debilitating bouts of breathlessness. It affects an estimated 329 million people worldwide and is predicted to be the third leading cause of death by 2030. Improving lung function and managing daily symptoms such as breathlessness are important to the management of COPD. It is estimated that eight out of 10 patients suffer symptoms at night, such as an irritative cough and difficulty breathing, frequent nocturnal awakenings, which leads to insomnia, worry and anxiety.

About AstraZeneca’s Co-Suspension Technology

The Co-Suspension Technology uses porous, low-density phospholipid particles, which are designed to form a uniform suspension inside a pressurised metered-dose inhaler (pMDI) and distribution of drug crystals throughout the lungs for release at their sites of deposition.

In addition, Co-Suspension Technology addresses issues often seen when multiple drugs are combined in a pMDI. This technology provides a stable, homogeneous suspension designed to prevent sedimentation of drug crystals over time and to prevent drug crystals from interacting with one another, thus allowing for consistent dosing of one or more different drugs from a single pMDI.

About the PINNACLE studies

The FDA approval of Bevespi Aerosphereis based on data from the PINNACLE 1, PINNACLE 2, and a safety extension study, PINNACLE 3. Overall the Phase III pivotal programme enrolled over 3,700 patients with moderate to very severe COPD.

Bevespi Aerospheredemonstrated statistically significant improvements in lung function as measured by change from baseline in morning pre-dose trough forced expiratory volume in 1 second (FEV1) at 24 weeks (p<0.001) versus its individual components (glycopyrrolate 9 mcg and formoterol fumarate 4.8 mcg) and placebo, all dosed twice daily.

Bevespi Aerospheredemonstrated a significant improvement versus placebo on secondary endpoints of peak FEV1within 2 hours post-dose, and rescue medication usage.

There were no unexpected safety findings with adverse events consistent with previous results from the development program. The most common adverse reactions with Bevespi Aerosphere, (with a ≥ 2% incidence and more common than with placebo) were urinary tract infection (2.6% vs 2.3% with placebo) and cough (4.0% vs 2.7% with placebo).

About Respiratory, Inflammation and Autoimmunity Diseases

Respiratory, Inflammation and Autoimmunity (RIA), one of AstraZeneca’s main therapy areas, has five potential medicines in pivotal trials or under registration. In respiratory disease, our aim is to transform asthma and COPD treatment through: Inhaled combinations at the core of care, precision biologics for the unmet needs of specific patient populations, and scientific advancements in disease modification. We are building on a 40-year heritage in respiratory disease, and our capability in inhalation technology spans both pressurised metered-dose inhalers (pMDIs) and dry powder inhalers (DPIs), as well as our unique Co-Suspension Technology.

In Inflammation and Autoimmunity, our aim is to develop innovative therapies for the treatment of autoimmune and rheumatoid diseases, with a lead programme in systemic lupus erythematosus. Across respiratory, inflammation and autoimmune diseases, our research is focused on four key treatable traits: eosinophilic disease, Th2-driven disease, epithelial-driven pathobiology,and autoimmunity.

About AstraZeneca

AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in three main therapy areas - respiratory, inflammation, autoimmune disease (RIA), cardiovascular and metabolic disease (CVMD) and oncology – as well as ininfection and neuroscience. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information please visit: www.astrazeneca.com

CONTACTS

Key: RIA - Respiratory, Inflammation and Autoimmunity, CVMD - Cardiovascular and Metabolic Disease,

ING - Infection, Neuroscience and Gastrointestinal