THOUSAND OAKS, Calif.,
Sept. 6, 2018 /PRNewswire/
-- Amgen (NASDAQ: AMGN) and AstraZeneca (NYSE: AZN) today
announced that the U.S. Food and Drug Administration (FDA) has
granted Breakthrough Therapy Designation for tezepelumab in
patients with severe asthma without an eosinophilic phenotype.
A Breakthrough Therapy Designation is designed to expedite the
development and regulatory review of medicines that are intended to
treat a serious condition and that have shown encouraging early
clinical results which may demonstrate substantial improvement on a
clinically-significant endpoint over available medicines.
The Breakthrough Therapy Designation is supported by the
tezepelumab Phase 2b PATHWAY data.
The trial showed a significant reduction in the annual asthma
exacerbation rate compared with placebo in a broad population of
severe asthma patients independent of baseline blood eosinophil
count or other type 2 (T2) inflammatory biomarkers. Currently
available biologic therapies only target T2 driven inflammation.
Tezepelumab is a potential first-in-class new medicine that blocks
thymic stromal lymphopoietin (TSLP) – an upstream modulator of
multiple inflammatory pathways.
"The Phase 2b PATHWAY trial data
demonstrated tezepelumab's promise as a novel therapeutic option
for a broad population of patients with severe asthma, including
those ineligible for currently approved biologic therapies," said
David M. Reese, M.D., executive vice
president of Research and Development at Amgen. "The Breakthrough
Designation will give us the opportunity to work closely with the
FDA to bring tezepelumab to patients as quickly as possible."
Tezepelumab is currently in development in the Phase 3
PATHFINDER clinical trial program.
About Severe Asthma
Asthma affects 334 million people
worldwide1, and up to 10 percent of asthma patients have
severe asthma, which may be uncontrolled despite high doses of
standard-of-care asthma controller medicines and can require the
use of chronic oral corticosteroids (OCS).2-4 Severe
uncontrolled asthma is debilitating with patients experiencing
frequent exacerbations and significant limitations on lung
function.5,6
Multiple inflammatory pathways are involved in the pathogenesis
of asthma.7 T2 inflammation-driven asthma, which
includes eosinophilic phenotype, is present in over two-thirds of
patients with severe asthma and is typically characterized by
elevated levels of T2 inflammatory biomarkers, including blood
eosinophils, serum IgE and fractional exhaled nitric oxide
(FeNO).8,9 Conversely, approximately one-third of
patients with severe asthma do not present with increased T2
inflammation.10
About Tezepelumab
Tezepelumab is a potential
first-in-class medicine blocking TSLP, an epithelial cytokine,
critical in the initiation and persistence of airway inflammation.
Blocking TSLP may prevent the release of pro-inflammatory cytokines
by immune cells resulting in the prevention of asthma exacerbations
and improved asthma control. Due to its activity early in the
inflammation cascade, tezepelumab may be suitable for a broad
population of patients with severe, uncontrolled asthma
irrespective of patient phenotype or T2 biomarker status.
Tezepelumab is being developed by AstraZeneca in collaboration with
Amgen.
About the PATHWAY Phase 2b
Trial
The PATHWAY Phase 2b
data were published in the New England Journal of
Medicine and presented at the European Respiratory Society
International Congress in September
2017. The trial evaluated the efficacy and safety of three
dose regimens of tezepelumab as an add-on therapy in patients with
a history of asthma exacerbations and uncontrolled asthma receiving
inhaled corticosteroids/long-acting beta-agonist with or without
oral corticosteroids and additional asthma controllers versus
placebo. The trial showed annual asthma exacerbation rate
reductions of 62 percent, 71 percent and 66 percent in the
tezepelumab arms receiving either 70 mg or 210 mg every four weeks
or 280 mg every two weeks compared to placebo (p<0.001
for all comparisons), respectively. These results were observed
independent of baseline blood eosinophil count or other T2
inflammatory biomarkers. The most common adverse events were
asthma-related, nasopharyngitis, headaches and bronchitis.
About the PATHFINDER Program
Building on the Phase
2b PATHWAY trial, the Phase 3
PATHFINDER program was initiated in the fourth quarter of 2017 with
two pivotal trials NAVIGATOR and SOURCE. The program includes
additional planned mechanistic and long-term safety trials.
NAVIGATOR is a Phase 3 multicenter, randomized, double-blinded,
parallel-group, placebo-controlled trial designed to evaluate the
efficacy and safety of a regular, subcutaneous administration of
tezepelumab for 52 weeks in adult and adolescent patients with
severe asthma inadequately controlled despite treatment with
inhaled corticosteroid (ICS) plus one additional asthma controller
medication.
SOURCE is a Phase 3 multicenter, randomized, double-blinded,
parallel-group, placebo-controlled trial for 48 weeks in adult
patients with severe asthma who require continuous treatment with
ICS plus long-acting beta-agonist (LABA), and chronic treatment
with maintenance oral corticosteroid (OCS) therapy.
About Amgen
Amgen is committed to unlocking
the potential of biology for patients suffering from serious
illnesses by discovering, developing, manufacturing and delivering
innovative human therapeutics. This approach begins by using tools
like advanced human genetics to unravel the complexities of disease
and understand the fundamentals of human biology.
Amgen focuses on areas of high unmet medical need and
leverages its expertise to strive for solutions that improve health
outcomes and dramatically improve people's lives. A biotechnology
pioneer since 1980, Amgen has grown to be one of the
world's leading independent biotechnology companies, has reached
millions of patients around the world and is developing a pipeline
of medicines with breakaway potential.
For more information, visit www.amgen.com and follow us on
www.twitter.com/amgen.
Amgen Forward-Looking Statements
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CONTACT: Amgen, Thousand Oaks
Kristen Davis, 805-447-3008
(media)
Kristen Neese, 805-313-8267
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References
- The Global Asthma Network. The Global Asthma Report 2014.
[Online]. Available at:
http://www.globalasthmanetwork.org/publications/Global_Asthma_Report_2014.pdf
[Last accessed 07 August 2018].
- Price D, Fletcher M, van der Molen T. Asthma control and
management in 8,000 European patients: the REcognise Asthma and
LInk to Symptoms and Experience (REALISE) survey. NPJ Prim Care
Respir Med 2014; 24: 14009.
- World Allergy Organization. The management of severe asthma:
economic analysis of the cost of treatments for severe asthma 2013.
http://www.worldallergy.org/educational_programs/world_allergy_forum/anaheim2005/blaiss.php
(accessed 10 July 2017).
- Adelphi real world respiratory disease specific programme.
[Asthma patient data file]. Bollington, UK. Uncited raw data, cited
with permission 2011–2014.
- Peters SP, Ferguson G, Deniz Y, et al. Uncontrolled asthma: a
review of the prevalence, disease burden and options for treatment.
Respir Med. 2006: 100(7):1139-51.
- Fernandes AG, Souza-Machado C, Coelho RC et al. Risk factors
for death in patients with severe asthma. J Bras Pneumol. 2014;
40(4): 364-372.
- Gauvreau GM, O'Byrne PM, Boulet LP, et al. Effects of an
anti-TSLP antibody on allergen-induced asthmatic responses. N Engl
J Med 2014;370:2102–10.
- Shaw DE, Sousa AR, Fowler SJ, et al. Clinical and inflammatory
characteristics of the European U-BIOPRED adult severe asthma
cohort. Eur Respir J 2015; 46(5): 1308–21.
- Fahy JV. Type 2 inflammation in asthma--present in most, absent
in many. Nat Rev Immunol 2015; 15(1): 57–65.
- Fajt ML, Wenzel SE. Development of New Therapies for Severe
Asthma. Allergy Asthma Immunol Res 2017; 9(1): 3–14.
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