Actelion receives Health Canada approval of Opsumit

18-Nov-2013 - Actelion Ltd announced that Health Canada has granted a Notice of Compliance (NOC) approving the orally available endothelin receptor antagonist OpsumitTM(macitentan) 10mg once daily for the treatment of pulmonary arterial hypertension (PAH). Opsumit (macitentan) is indicated in Canada, for the ...

Actelion submits the registration dossier for macitentan to EMA

23-Nov-2012 - Actelion announced that the submission of the Marketing Authorisation Application (MAA) for macitentan (Opsumit®) for the treatment of patients with pulmonary arterial hypertension to the EMA has been accepted. The EMA will now start the formal review process.The United States Food and Drug ...

Actelion submits a NDA for macitentan for the treatment of patients with pulmonary arterial hypertension

23-Oct-2012 - Actelion announced that it has submitted a New Drug Application (NDA) to the US Food and Drug Administration (FDA) seeking approval for macitentan (Opsumit®) for the treatment of patients with pulmonary arterial hypertension.Macitentan, a novel oral dual endothelin receptor antagonist, was ...

Actelion's macitentan meets primary endpoint in pivotal Phase III study

03-May-2012 - Actelion announced that initial analysis indicates that the pivotal, long-term, event-driven study SERAPHIN with macitentan, a novel dual endothelin receptor antagonist, in 742 patients suffering from pulmonary arterial hypertension (PAH) and treated for up to three and a half years, has met its ...

BUILD-3 study with bosentan in idiopathic pulmonary fibrosis does not meet primary endpoint

02-Mar-2010 - Actelion Ltd announced the initial results of BUILD-3, a clinical study evaluating the safety and efficacy of bosentan in patients suffering from idiopathic pulmonary fibrosis. While there was a consistent trend in favor of bosentan, the primary endpoint, reduction in morbidity/mortality, was ...

Tracleer receives label extension in the US

10-Aug-2009 - Actelion Ltd announced that the U.S. Food and Drug Administration (FDA) has approved the company's supplemental New Drug Application (sNDA) for Tracleer® (bosentan) to treat patients with mildly symptomatic WHO Functional Class II (FC II) pulmonary arterial hypertension (PAH). The U.S. FDA has ...

Actelion's PGI2 receptor agonist demonstrates efficacy in pulmonary arterial hypertension patients

Morbidity-Mortality Phase III study to be initiated before year-end

20-Jul-2009 - Actelion Ltd announced that positive data have been obtained in a Phase IIa study with its first-in-class orally active non-prostanoid PGI2 receptor agonist in pulmonary arterial hypertension (PAH) patients. In the 43 patient placebo-controlled double-blind study to assess efficacy, safety and ...

Tracleer (bosentan) receives EU approval for pediatric formulation

The first and only licensed pulmonary arterial hypertension therapy for children

07-Jul-2009 - Actelion Ltd announced that the pediatric dispersible formulation of Tracleer® (bosentan) for the treatment of pulmonary arterial hypertension (PAH) in children has been approved in the European Union. This approval makes Tracleer® the only PAH therapy with an approved pediatric formulation for ...

Bosentan (Tracleer) receives positive CHMP opinion for pediatric formulation

28-Apr-2009 - 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 the pediatric formulation of bosentan (Tracleer®) for the treatment of pulmonary arterial hypertension (PAH). The ...

Actelion Pharmaceuticals Ltd - Bosentan receives positive EU opinion

30-Jun-2008 - 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 ...