(1888PressRelease)
April 28, 2009 - Actelion Ltd (SIX: ATLN) announced today that the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMEA), issued a positive opinion for the pediatric formulation of bosentan (TracleerŪ) for the treatment of pulmonary arterial hypertension (PAH).
The CHMP recommended that the European Commission approves the new dispersible 32mg tablet formulation of bosentan, which was specifically developed for children, and which was studied in children with PAH down to the age of two years in the pediatric program. The European Commission is expected to make a final decision within two months. Actelion continues to work with authorities world-wide, including the US, to authorize the new dispersible formulation and to expand the PAH product information for bosentan bringing the treatment age down to 2 years of age.
Bosentan is an oral, dual endothelin receptor antagonist, which is already approved as TracleerŪ in Europe for the treatment of PAH; in WHO functional class III PAH to improve exercise capacity and symptoms and in PAH WHO Functional Class II where some improvements have also been shown [1]. In the EU, TracleerŪ is also indicated to reduce the number of new digital ulcers in patients with systemic sclerosis and ongoing digital ulcer disease.
PAH is a severe condition in children with an estimated median survival of 10 months, if left untreated, after diagnosis [2]. Currently, no drug is indicated for the treatment of PAH in children below 12 years of age; once licensed, bosentan will be the only PAH treatment with a pediatric formulation.
The pediatric program investigated the, pharmacokinetics, tolerability and safety of the new dispersible formulation of bosentan. The safety profile was consistent with that seen in the adult population.
The new, quadrisect, dispersible 32mg tablet formulation, specifically developed for children above the age of 2 years, allows for simple dose calculation and administration.
For further information please contact:
Medical Media Contact
Elizabeth Perry
Packer Forbes
+44 208 772 1551
elizabeth ( @ ) packerforbes dot com
Investor Contact
Roland Haefeli
Vice President, Head of Investor Relations & Public Affairs
Actelion Pharmaceuticals Ltd, Gewerbestrasse 16, CH-4123 Allschwil
+41 61 565 62 62
+1 650 624 69 36
http://www.actelion.com
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