TIDMAZN
RNS Number : 2872O
AstraZeneca PLC
01 October 2019
This announcement contains inside information
01 October 2019 07:00 BST
Update on US regulatory review of PT010 in COPD
AstraZeneca today announced that the US Food and Drug
Administration (FDA) has issued a complete response letter
regarding the New Drug Application (NDA) for PT010
(budesonide/glycopyrronium/formoterol fumarate), an inhaled
triple-combination therapy and potential new medicine for patients
with chronic obstructive pulmonary disease (COPD).
The NDA submitted to the FDA by AstraZeneca included data from
the Phase III trial KRONOS. The Company will now work closely with
the FDA regarding next steps, including submitting for review
recent results from the second positive Phase III trial, ETHOS,
which was not completed at the time the NDA was submitted.
PT010 was approved in Japan in June 2019 as Breztri Aerosphere,
a triple-combination therapy to relieve symptoms of COPD. PT010 is
under regulatory review in China where it has been granted priority
review by the National Medical Products Administration, and is also
under regulatory review in the EU.
About COPD
COPD is a progressive disease which can cause obstruction of
airflow in the lungs resulting in debilitating bouts of
breathlessness.(1) It affects an estimated 384 million people
worldwide and is predicted to be the third leading cause of death
by 2020.(1,2) Improving lung function, reducing exacerbations and
managing daily symptoms such as breathlessness are important
treatment goals in the management of COPD.(1)
About ATHENA
ATHENA is PT010's global clinical trial programme, including 11
completed Phase III trials with more than 15,500 patients.(3,4,5,6)
The four key trials are ETHOS, KRONOS, TELOS and SOPHOS.(3,4,5,6)
The ETHOS and KRONOS trials assessed the efficacy and safety of
PT010.(3,4) The TELOS and SOPHOS trials characterised PT009 and
substantiated it as an active comparator in the PT010 clinical
trial programme.(5,6)
In the Phase III ETHOS trial, PT010 demonstrated a
statistically-significant reduction in the rate of moderate or
severe exacerbations compared with dual-combination therapies
Bevespi Aerosphere (glycopyrronium/formoterol fumarate) and PT009
(budesonide/formoterol fumarate). The safety and tolerability of
PT010 in the trial were consistent with the known profiles of the
dual comparators.(7)
About PT010
PT010 is a fixed-dose triple-combination of budesonide, an
inhaled corticosteroid with glycopyrronium, a long-acting
muscarinic agonist, and formoterol fumarate, a long-acting
beta2-agonist, delivered in a pressurised metered-dose inhaler.
Under the terms of the agreement to acquire Pearl Therapeutics
Inc., AstraZeneca anticipates making a $150m milestone payment upon
US regulatory approval of PT010 for COPD. This payment would be the
final development and regulatory milestone under that
agreement.
About AstraZeneca in respiratory diseases
Respiratory is one of AstraZeneca's three therapy areas, and our
medicines reached more than 18 million patients as maintenance
therapy in 2018. AstraZeneca's aim is to transform asthma and COPD
treatment through inhaled combinations at the core of care,
biologics for the unmet needs of specific patient populations, and
scientific advancements in disease modification.
The Company is building on a 40-year heritage in respiratory
disease and AstraZeneca's capability in inhalation technology spans
pressurised metered-dose inhalers and dry powder inhalers, as well
as the Aerosphere delivery technology.
The company also has a growing portfolio of respiratory
biologics including Fasenra (anti-eosinophil, anti-IL5 receptor
alpha), now approved for severe eosinophilic asthma and in
development for severe nasal polyposis and COPD and a number of
other potential indications, and tezepelumab (anti-TSLP), which has
been granted Breakthrough Therapy Designation by the US Food and
Drug Administration in patients with severe asthma, and is in Phase
III trials.
AstraZeneca's research is focused on addressing underlying
disease drivers focusing on the lung epithelium, lung immunity and
lung regeneration.
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 - Oncology, Cardiovascular, Renal and
Metabolism (CVRM) and Respiratory. AstraZeneca operates in over 100
countries and its innovative medicines are used by millions of
patients worldwide. Please visit astrazeneca.com and follow us on
Twitter @AstraZeneca.
Media Relations
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References
1. GOLD. Global Strategy for the Diagnosis, Management and
Prevention of COPD, Global Initiative for Chronic Obstructive Lung
Disease (GOLD) 2019. [Online]. Available at: http://goldcopd.org.
Last accessed: September 2019.
2. Adeloye D, Chua S, Lee C, et al. Global Health Epidemiology
Reference Group (GHERG). Global and regional estimates of COPD
prevalence: Systematic review and meta-analysis. J Glob Health.
2015; 5 (2): 020415.
3. Clinicaltrials.gov. A Randomized, Double-Blind,
Parallel-Group, 24-Week, Chronic-Dosing, Multi-Center Study to
Assess the Efficacy and Safety of PT010, PT003, and PT009 Compared
With Symbicort(R) Turbuhaler(R) (Kronos) (KRONOS). [Online].
Available at: https://clinicaltrials.gov/ct2/show/NCT02497001. Last
accessed: September 2019.
4. Clinicaltrials.gov. Study to Assess the Efficacy and Safety
of PT010 Relative to PT003 and PT009 in Subjects With Moderate to
Very Severe COPD (ETHOS). [Online]. Available at:
https://clinicaltrials.gov/ct2/show/NCT02465567 Last accessed:
September 2019.
5. Clinicaltrials.gov. Study to Assess Efficacy and Safety of
PT009 Compared to PT005, PT008, and Symbicort(R) Turbuhaler(R) on
Lung Function Over 24-Weeks in Subjects With Moderate to Very
Severe COPD (TELOS). [Online]. Available at:
https://clinicaltrials.gov/ct2/show/NCT02766608. Last accessed:
September 2019.
6. Clinicaltrials.gov. A Study to Assess the Efficacy and Safety
of PT009 Compared to PT005 on COPD Exacerbations Over a 52-Week
Period in Subjects With Moderate to Very Severe COPD (SOPHOS).
[Online]. Available at:
https://clinicaltrials.gov/ct2/show/NCT02727660. Last accessed:
September 2019.
7. Rabe KF et al. A phase III study of triple therapy with
budesonide/glycopyrrolate/formoterol fumarate metered dose inhaler
320/18/9.6 <MU>g and 160/18/9.6 <MU>g using
co-suspension delivery technology in moderate-to-very severe COPD:
The ETHOS study protocol. Respir Med. 2019 Aug 22; DOI:
10.1016/j.rmed.2019.08.010.
Adrian Kemp
Company Secretary
AstraZeneca PLC
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