Actelion Ltd today announced the approval of Opsumit (macitentan) 10 mg for the treatment of pulmonary arterial hypertension (PAH) by the Therapeutic Goods Administration (TGA) of Australia.

Actelion’s PAH Treatment Recieves Therapeutic Approval in Australia

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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.

February 7th, 2014

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.

“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.”Jean-Paul Clozel, M.D. and Chief Executive Officer of Actelion

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.

 

See the press release here.
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