Actelion Ltd (SWX: ATLN) announced that Tracleer® (bosentan), a dual endothelin receptor antagonist, has been approved in the European Union for the treatment of patients with mildly symptomatic pulmonary arterial hypertension (PAH WHO functional class FC II). Buy acomplia pills Since 2002, Tracleer® has been approved and available in the European Union for PAH patients with WHO FC III.
Tracleer® is the first PAH treatment ever to be investigated in a clinical study that exclusively enrolled patients with mildly symptomatic WHO FC II. This 185-patient randomized, double-blind, placebo-controlled study provided the basis for this EU approval. The indication extension reads: "Some improvements have also been shown in patients with PAH WHO functional class II (see section 5.1)" 1
Jean-Paul Clozel, M.D. and Chief Executive Officer of Actelion, commented: "The EARLY study has demonstrated that even patients with mild symptoms are at risk of rapid deterioration. I am very proud that Actelion - together with the scientific community - has been able to demonstrate the important role of Tracleer® in delaying disease progression in these patients. Our dual endothelin receptor antagonist Tracleer® is the only PAH medicine to have demonstrated a delay in disease progression in three independent placebo-controlled, randomized clinical studies. Actelion will now communicate these important clinical findings to encourage early diagnosis and intervention."
The results from EARLY (Endothelin Antagonist tRial in miLdlY symptomatic PAH patients) published in "The Lancet" in June2, document the relentlessly progressive nature of PAH, even in its early stages, and highlight the need for earlier treatment and intervention in PAH management. The PAH progression was evident from the deterioration in all evaluated parameters in the placebo group, including the rate of clinical worsening events. The primary endpoints for the EARLY trial were changes in pulmonary vascular resistance (PVR) and exercise capacity as measured by a 6-minute walk test (6MWD). PAH progression was assessed by evaluating two secondary endpoints which were time to clinical worsening and change in WHO functional class.
The key results of the EARLY study were:
- PVR improved significantly, with a reduction of 22.6 percent (p Buy zithromax pills | generic cipro online buy | Buy levitra pills