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2016-07-21

AstraZeneca: AstraZeneca's antibiotic Zavicefta met primary endpoints in phase III trial for treatment of hospital-acquired pneumonia

AstraZeneca today announced positive results from the Phase III
REPROVE trial for Zavicefta (ceftazidime-avibactam), a new
combination antibiotic for the treatment of a broad range of serious
Gram-negative bacterial infections in hospitalised patients.
Zavicefta has been developed in response to the urgent need for new
antibiotics to treat serious infections that are becoming
increasingly resistant to current antibiotics commonly used for
serious infections, such as carbapenems and polymixins, including
colistin.

The REPROVE trial assessed the efficacy of Zavicefta
(ceftazidime-avibactam) compared with meropenem in the treatment of
adult patients with hospital-acquired pneumonia (HAP), including
ventilator-associated pneumonia (VAP). Zavicefta met the primary
objective of statistical non-inferiority compared to meropenem at the
test of cure visit (day 21 from randomisation). All-cause mortality
rate at day 28 from randomisation was also similar in the two groups.
Safety observed in the trial was consistent with the known safety
profiles of both antibiotics. Full results from REPROVE are expected
to be presented at future scientific meetings.

Hans Sijbesma, Managing Director, AstraZeneca Antibiotics Business
Unit, said: "The positive results from this important Phase III trial
validate our science-led approach and confirm the effectiveness of
Zavicefta in treating hospital-acquired pneumonia, providing patients
and physicians with a much-needed new treatment option in the fight
against antibiotic-resistant pathogens."

On 24 June 2016, Zavicefta was approved by the European Commission for
intravenous use in the treatment of adult patients suffering from
HAP, including VAP, as well as: Complicated intra-abdominal
infections (cIAI); complicated urinary tract infections (cUTI),
including pyelonephritis; and the treatment of aerobic Gram-negative
infections in adult patients who have limited treatment options.

- ENDS -

NOTES TO EDITORS

About REPROVE

REPROVE is a Phase III, randomised, multi-centre, double-blind,
double-dummy, parallel-group, comparative trial to determine the
efficacy, safety and tolerability of ceftazidime-avibactam
administered intravenously as a two-hour infusion (2000 mg / 500 mg,
every 8 hours, compared to meropenem, administered intravenously as a
30 minute infusion (1000 mg every 8 hours). A total of 879 patients
were randomised to the REPROVE trial from 23 countries.

The primary endpoint was assessed in the clinically modified
intent-to-treat (cMITT) and clinically evaluable (CE) trial
populations. The cMITT population consists of all patients dosed who
met clinical disease criteria, had microbiologically confirmed
Gram-negative respiratory pathogens (with or without concomitant
Gram-positive pathogens) and in whom no specific, disease-causing
(e.g. etiologic) pathogens were identified. Patients with infections
caused by Gram-negative pathogens not expected to respond to either
trial drug were excluded from the cMITT analysis. The CE population
consists of patients who met the cMITT criteria and also had an
evaluable assessment, no important protocol deviations that would
affect efficacy, received adequate treatment and received no
unacceptable prior/concomitant antibiotics.

The non-inferiority margin was 12.5%.

About Zavicefta
Zavicefta (ceftazidime-avibactam) is a combination antibiotic that has
been developed to treat serious Gram-negative bacterial infections.
It consists of a combination of avibactam and ceftazidime - a third
generation antipseudomonal cephalosporin with a well-established
efficacy and safety profile. Avibactam is a first-in-class
broad-spectrum ?-lactamase inhibitor, which protects ceftazidime
against degradation by Class A, C and some D ?-lactamases.

Zavicefta offers a differentiated profile versus existing treatment
options in serious Gram-negative infections through its coverage of a
broad range Enterobacteriaceae species, including those that produce
ESBL and KPC, together with activity against difficult-to-treat P.
aeruginosa.

Zavicefta has previously demonstrated non-inferiority to comparators
in Phase III trials in hospitalised adult patients with cIAI (RECLAIM
1 and 2) and cUTI (RECAPTURE 1 and 2). In addition, Zavicefta
demonstrated statistically significant superior efficacy compared to
doripenem for the European Medicines Agency-specified primary
endpoint in the RECAPTURE trials. In the REPRISE trial, which
evaluated the efficacy and safety of Zavicefta in patients with cIAI
or cUTI infections caused by ceftazidime-resistant Gram-negative
pathogens, efficacy was similar to best available treatment, and
substantially higher microbiological cure rates were observed in cUTI
patients treated with Zavicefta.

Ceftazidime-avibactam is being jointly developed by AstraZeneca and
Allergan. AstraZeneca holds the global rights to commercialise
Zavicefta, with the exception of North America, where the rights are
held by Allergan.

About Hospital-Acquired Pneumonia (HAP) including
Ventilator-Associated Pneumonia (VAP)

Hospital-acquired pneumonia (HAP), also known as nosocomial pneumonia,
refers to the development of lung infections after a patient has been
hospitalised for a minimum of 48 hours. If, after 48 hours, the
infection develops during the use of intubation and mechanical
ventilation, the condition is then called ventilator-associated
pneumonia (VAP).

VAP is generally a severe illness, with patients requiring treatment
in the intensive care unit (ICU). Some non-intubated patients with
HAP can have either mild or more severe pneumonia.

Nosocomial pneumonia and HAP have similar clinical characteristics and
the terms are often used interchangeably.

About AstraZeneca

AstraZeneca is a global, science-led biopharmaceutical company that
focuses on the discovery, development and commercialisation of
prescription medicines, primarily for the treatment of diseases in
three therapy areas - Respiratory and Autoimmunity, Cardiovascular
and Metabolic Diseases, and Oncology. The company is also active in
inflammation, infection and neuroscience through numerous
collaborations. 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

Media Enquiries
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Michele Meixell US +1 302 885 2677
Investor Relations
UK
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Craig Marks Finance, Fixed Income, M&A +44 7881 615 764
Nick Stone Respiratory & Autoimmunity +44 203 749 5716
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Christer Gruvris Infection & Neuroscience +44 203 749 5711
US
Lindsey Trickett Cardiovascular & Metabolic Diseases +1 240 543 7970
Mitchell Chan Oncology +1 240 477 3771
Toll-free +1 866 381 7277

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