Actelion Pharmaceuticals Ltd - Bosentan receives positive EU opinion
Actelion Ltd announced that the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMEA), issued a positive opinion for bosentan (Tracleer®) to extend its use in pulmonary arterial hypertension (PAH).
The CHMP recommended that the European Commission approve bosentan (Tracleer®) for the treatment of PAH in WHO Functional Class II (FC II) patients based on the EARLY study results. The extension of the indication recommended by CHMP reads: "Some improvements have also been shown in patients with PAH WHO functional class II." The European Commission decision is expected within the next 2-3 months.
Tracleer® is an oral dual endothelin receptor antagonist, which is currently licensed for the treatment of PAH; in Europe in PAH FC III to improve exercise capacity and symptoms and in the United States in PAH FC III and IV to improve exercise capacity and decrease the rate of clinical worsening.1 Actelion is working with authorities in the US and in other countries worldwide to expand the label for Tracleer® to include WHO FC II. In the EU, Tracleer® is also indicated to reduce the number of new digital ulcers in patients with systemic sclerosis and ongoing digital ulcer disease.
There are four WHO functional classes for PAH with class I being the least severe and class IV being the most advanced. These reflect the impact on a patient's life in terms of symptoms and physical activity. FC II patients are defined as patients with PAH resulting in slight limitation of physical activity, they are comfortable at rest and ordinary physical activity causes undue dyspnea or fatigue, chest pain or near syncope2.
Despite being mildly symptomatic, PAH patients in WHO functional class II suffer from a severe disease. EARLY (Endothelin Antagonist tRial in miLdlY symptomatic PAH patients), the only randomized controlled trial to exclusively study FC II patients, highlights rapid progression of PAH, regardless of symptoms and shows the benefit of treating these patients with Tracleer®. The study was recently published in "The Lancet" 3.
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