Actelion is granted Marketing Authorisation for Opsumit (macitentan) in Pulmonary Arterial Hypertension (PAH) by the European Commission
-1 of 3- 20 Dec 2013 16:35:00 UTC *DJ Actelion is granted Marketing Authorisation for Opsumit (macitentan) in Pulmonary Arterial Hypertension (PAH) by the European Commission
December 20, 2013 11:35 ET (16:35 GMT)- - 11 35 AM EST 12-20-13
-2 of 3- 20 Dec 2013 16:35:00 UTC Press Release: Actelion is granted Marketing Authorisation for Opsumit (macitentan) in Pulmonary Arterial Hypertension (PAH) by the European Commission
Actelion Pharmaceuticals Ltd / Actelion is granted Marketing Authorisation for Opsumit (macitentan) in Pulmonary Arterial Hypertension (PAH) by the European Commission . Processed and transmitted by Nasdaq OMX Corporate Solutions. The issuer is solely responsible for the content of this announcement.
-- Approval granted by European Commission on 20 December 2013
-- Opsumit approved as monotherapy or in combination with another PAH therapy for the long-term treatment of WHO Functional Class II to III PAH patients
-- First EU launch planned in Germany in February 2014
ALLSCHWIL, SWITZERLAND - 20 December 2013 - Actelion Ltd (SIX: ATLN) today announced that Opsumit(R) (macitentan), a novel dual endothelin receptor antagonist (ERA), has been granted marketing authorisation for the long-term treatment of PAH in the EU by the European Commission. Opsumit, as monotherapy or in combination, is indicated for the longterm treatment of pulmonary arterial hypertension (PAH) in adult patients of WHO Functional Class (FC) II to III.
Efficacy has been shown in a PAH population including idiopathic and heritable PAH, PAH associated with connective tissue disorders, and PAH associated with corrected simple congenital heart disease.
Macitentan 10mg is also described as reducing the risk of PAH related death or hospitalization for PAH up to end of treatment (EOT) by 50% (HR 0.50; 97.5% CI: 0.34 to 0.75; logrank p < 0.0001). Macitentan 10mg improved quality of life assessed by the SF-36 questionnaire.
Dr Nazzareno Galiè from the Institute of Cardiology, University of Bologna, Bologna, Italy spoke of the impact of the availability of Opsumit, "We are all very pleased with the approval of Opsumit in Europe. For the first time we can offer patients a therapy that has demonstrated improvement in long term clinical outcome showing a significant effect in naive patients and patients who are already on a specific PAH treatment."
The EU label was based in part on data from the landmark Phase III SERAPHIN study which was published in the New England Journal of Medicine in August 2013, the SERAPHIN study demonstrated that treatment with macitentan 10 mg resulted in a 45% risk reduction (hazard ratio [HR] 0.55; 97.5% CI: 0.39 to 0.76; p < 0.0001) of the composite morbidity-mortality endpoint up to (EOT) when compared to placebo.[1]
Jean-Paul Clozel, M.D. and Chief Executive Officer of Actelion commented: "We are delighted with today's announcement as we believe that Opsumit represents a major step forward for the management of PAH. Our company strategy of sustaining and growing our PAH franchise has yet again been bolstered by this approval. This achievement marks a significant moment for the PAH community in Europe as the first and only PAH treatment with proven long-term efficacy, from controlled clinical trials in PAH, and will now offer hope of a better future to those living with this disease. Actelion is now working to make this important medicine available to patients around European markets in the coming months."
The most commonly reported adverse drug reactions are nasopharyngitis (14.0%), headache (13.6%) and anaemia (13.2%). The majority of adverse reactions are mild to moderate in intensity.
Opsumit was approved by the FDA on 18 October 2013 and by Health Canada in November 2013. It is also undergoing regulatory assessment in other countries including Switzerland.
-2 of 3- 20 Dec 2013 16:35:00 UTC Press Release: Actelion is granted Marketing Authorisation for Opsumit (macitentan) in Pulmonary Arterial Hypertension (PAH) by the European Commission
Actelion Pharmaceuticals Ltd / Actelion is granted Marketing Authorisation for Opsumit (macitentan) in Pulmonary Arterial Hypertension (PAH) by the European Commission . Processed and transmitted by Nasdaq OMX Corporate Solutions. The issuer is solely responsible for the content of this announcement.
-- Approval granted by European Commission on 20 December 2013
-- Opsumit approved as monotherapy or in combination with another PAH therapy for the long-term treatment of WHO Functional Class II to III PAH patients
-- First EU launch planned in Germany in February 2014
ALLSCHWIL, SWITZERLAND - 20 December 2013 - Actelion Ltd (SIX: ATLN) today announced that Opsumit(R) (macitentan), a novel dual endothelin receptor antagonist (ERA), has been granted marketing authorisation for the long-term treatment of PAH in the EU by the European Commission. Opsumit, as monotherapy or in combination, is indicated for the longterm treatment of pulmonary arterial hypertension (PAH) in adult patients of WHO Functional Class (FC) II to III.
Efficacy has been shown in a PAH population including idiopathic and heritable PAH, PAH associated with connective tissue disorders, and PAH associated with corrected simple congenital heart disease.
Macitentan 10mg is also described as reducing the risk of PAH related death or hospitalization for PAH up to end of treatment (EOT) by 50% (HR 0.50; 97.5% CI: 0.34 to 0.75; logrank p < 0.0001). Macitentan 10mg improved quality of life assessed by the SF-36 questionnaire.
Dr Nazzareno Galiè from the Institute of Cardiology, University of Bologna, Bologna, Italy spoke of the impact of the availability of Opsumit, "We are all very pleased with the approval of Opsumit in Europe. For the first time we can offer patients a therapy that has demonstrated improvement in long term clinical outcome showing a significant effect in naive patients and patients who are already on a specific PAH treatment."
The EU label was based in part on data from the landmark Phase III SERAPHIN study which was published in the New England Journal of Medicine in August 2013, the SERAPHIN study demonstrated that treatment with macitentan 10 mg resulted in a 45% risk reduction (hazard ratio [HR] 0.55; 97.5% CI: 0.39 to 0.76; p < 0.0001) of the composite morbidity-mortality endpoint up to (EOT) when compared to placebo.[1]
Jean-Paul Clozel, M.D. and Chief Executive Officer of Actelion commented: "We are delighted with today's announcement as we believe that Opsumit represents a major step forward for the management of PAH. Our company strategy of sustaining and growing our PAH franchise has yet again been bolstered by this approval. This achievement marks a significant moment for the PAH community in Europe as the first and only PAH treatment with proven long-term efficacy, from controlled clinical trials in PAH, and will now offer hope of a better future to those living with this disease. Actelion is now working to make this important medicine available to patients around European markets in the coming months."
The most commonly reported adverse drug reactions are nasopharyngitis (14.0%), headache (13.6%) and anaemia (13.2%). The majority of adverse reactions are mild to moderate in intensity.
Opsumit was approved by the FDA on 18 October 2013 and by Health Canada in November 2013. It is also undergoing regulatory assessment in other countries including Switzerland.
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