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- TGA approval for Opsumit (macitentan)
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Actelion receives Therapeutic Goods Administration (TGA) approval in Australia for Opsumit (macitentan) in Pulmonary Arterial Hypertension (PAH)


 ALLSCHWIL/BASEL, SWITZERLAND – 07 February 2014 – Actelion Ltd (SIX: ATLN) today announcedthe approval of Opsumit® (macitentan) 10 mg for the treatment of pulmonary arterial hypertension (PAH) by the Therapeutic Goods Administration (TGA) of Australia. 

Opsumit, as monotherapy or in combination with approved PAH treatments (phosphodiesterase-5 inhibitors or inhaled prostanoids), is indicated for the treatment of idiopathic and heritable PAH as well as PAH associated with connective tissue disease and PAH associated with congenital heart disease with repaired shunts in patients with WHO Functional class II,III or IV symptoms. 

Professor Trevor Williams, Clinical Director of the Department of Allergy, Immunology and Respiratory Medicine at Alfred Hospital and Monash University, Melbourne, Australia commented, “The approval of Opsumit is a key milestone in the management of PAH. We now have confidence that we can improve long term clinical outcomes both in treatment naïve patients and those on combination therapy. Hopefully all new pulmonary arterial hypertension drugs will be subjected to such extensive level of rigorous clinical evaluation and demonstrate clinically important results.” 

The TGA's approval was based on data from the landmark Phase III SERAPHIN study. In the SERAPHIN study, treatment with macitentan 10 mg resulted in a 45% risk reduction (hazard ratio [HR] 0.55; 97.5% CI: 0.39 to 0.76; logrank p < 0.0001) of the composite morbidity-mortality endpoint when compared to placebo. 

Jean-Paul Clozel, M.D. and Chief Executive Officer of Actelion gave his reaction to the news: "This approval marks a significant moment for the PAH community in Australia as Opsumit is the first and only PAH treatment with proven long-term efficacy in 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 Australia in the coming months." 

The most common adverse events that were reported at a frequency at least 3% greater on macitentan than on placebo were nasopharyngitis (14.0% macitentan vs 10.4% placebo), headache (13.6% vs 8.8%) and anaemia (13.2% vs 3.2%) 

Opsumit was approved by the US FDA in October 2013, Health Canada in November 2013 and by the EU Commission in December 2013. It is also undergoing regulatory assessment in other countries including Switzerland.

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