Actelion obtains "Epoprostenol ACT" label extension for pediatric PAH patients in Japan
(Thomson Reuters ONE) -
Actelion Pharmaceuticals Ltd /
Actelion obtains "Epoprostenol ACT" label extension for pediatric PAH patients
in Japan
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The issuer is solely responsible for the content of this announcement.
ALLSCHWIL, SWITZERLAND - 02 March 2017 - Actelion (SIX: ATLN) announced today
that Japan's Ministry of Health, Labor and Welfare granted a label extension for
dosage and administration for "Epoprostenol ACT" (0.5 mg and 1.5 mg) for the
treatment of pediatric patients with pulmonary arterial hypertension (PAH).
Dr. Satoshi Tanaka, President of Actelion Japan and Chairman of Actelion South
Korea, commented: "Epoprostenol ACT" is the first epoprostenol to receive the
pediatric indication in Japan. Adding this patient population to the product
label allows us to offer physicians in Japan an option for intravenous therapy
for young patients with advanced pulmonary arterial hypertension. "Epoprostenol
ACT" will provide these patients and their families and caretakers with benefits
that will make managing the disease easier, including greater stability of the
medication and more flexibility with its preparation and administration."
Actelion Pharmaceuticals Japan will now work closely with all partners involved
to ensure that "Epoprostenol ACT" is made available to pediatric patients as
soon as possible.
Marketed in Japan as "Epoprostenol ACT", Veletri(®) (epoprostenol for
injection), an intravenous prostacyclin, is commercially available in 17 markets
worldwide, including the US (since 2010), Switzerland and - marketed as
Caripul(®) - Canada (since 2012), as well as Japan and some European markets
(since 2013). The registration process for other countries is ongoing.
###
Notes to the Editor
ABOUT PULMONARY ARTERIAL HYPERTENSION (PAH)
PAH is a chronic, life-threatening disorder characterized by abnormally high
blood pressure in the arteries between the heart and lungs of an affected
individual. The symptoms of PAH are non-specific and can range from mild
breathlessness and fatigue during normal daily activity to symptoms of right
heart failure and severe restrictions on exercise capacity and ultimately
reduced life expectancy. PAH is one group within the classification of pulmonary
hypertension (PH). This group includes idiopathic PAH, heritable PAH and PAH
caused by factors which include connective tissue disease, HIV infection and
congenital heart disease.
The last decade has seen significant advances in the understanding of the
pathophysiology of PAH, which has been paralleled with developments of treatment
guidelines and new therapies. Drugs targeting the three pathways that have been
established in the pathogenesis of PAH are endothelin receptor antagonists
(ERAs), prostacyclin receptor agonists, and phosphodiesterase-5 inhibitors. PAH
treatments have transformed the prognosis for PAH patients from symptomatic
improvements in exercise tolerance 10 years ago to delayed disease progression
today. Improved disease awareness and evidence-based guidelines developed from
randomized controlled clinical trial data have highlighted the need for early
intervention, goal-oriented treatment and combination therapy. Learn more
at http://www.pahuman.com/
ABOUT ACTELION LTD.
Actelion Ltd. is a leading biopharmaceutical company focused on the discovery,
development and commercialization of innovative drugs for diseases with
significant unmet medical needs.
Actelion is a leader in the field of pulmonary arterial hypertension (PAH). Our
portfolio of PAH treatments covers the spectrum of disease, from WHO Functional
Class (FC) II through to FC IV, with oral, inhaled and intravenous medications.
Although not available in all countries, Actelion has treatments approved by
health authorities for a number of specialist diseases including Type 1 Gaucher
disease, Niemann-Pick type C disease, Digital Ulcers in patients suffering from
systemic sclerosis, and mycosis fungoides type cutaneous T-cell lymphoma.
Founded in late 1997, with now over 2,600 dedicated professionals covering all
key markets around the world including Europe, the US, Japan, China, Russia and
Mexico, Actelion has its corporate headquarters in Allschwil / Basel,
Switzerland.
Actelion shares are traded on the SIX Swiss Exchange (ticker symbol: ATLN) as
part of the Swiss blue-chip index SMI (Swiss Market Index SMI(®)). All
trademarks are legally protected by their respective owners.
For further information, please contact:
Andrew Weiss
Senior Vice President, Head of Investor Relations & Corporate Communications
Actelion Pharmaceuticals Ltd, Gewerbestrasse 16, CH-4123 Allschwil
+41 61 565 62 62
www.actelion.com
The above information contains certain "forward-looking statements", relating to
the company's business, which can be identified by the use of forward-looking
terminology such as "estimates", "believes", "expects", "may", "are expected
to", "will", "will continue", "should", "would be", "seeks", "pending" or
"anticipates" or similar expressions, or by discussions of strategy, plans or
intentions. Such statements include descriptions of the company's investment
and research and development programs and anticipated expenditures in connection
therewith, descriptions of new products expected to be introduced by the company
and anticipated customer demand for such products and products in the company's
existing portfolio. Such statements reflect the current views of the company
with respect to future events and are subject to certain risks, uncertainties
and assumptions. Many factors could cause the actual results, performance or
achievements of the company to be materially different from any future results,
performances or achievements that may be expressed or implied by such forward-
looking statements. Should one or more of these risks or uncertainties
materialize, or should underlying assumptions prove incorrect, actual results
may vary materially from those described herein as anticipated, believed,
estimated or expected.
Press release PDF:
http://hugin.info/131801/R/2083569/785425.pdf
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Source: Actelion Pharmaceuticals Ltd via GlobeNewswire
Unternehmensinformation / Kurzprofil:
Datum: 02.03.2017 - 07:00 Uhr
Sprache: Deutsch
News-ID 527622
Anzahl Zeichen: 7450
contact information:
Town:
Allschwil
Kategorie:
Business News
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