The Australian government's Therapeutic Goods Administration approved the use of Alexion's Soliris for the treatment of patients suffering from paroxysmal nocturnal hemoglobinuria (PNH). The sanction reportedly makes Soliris the only treatment for the condition in the country.
The Australian federal healthcare officials are expected to make a decision regarding funding for the treatment by the end of the year. The drug was approved by the FDA and European Commission in 2007 and by Health Canada in January 2009. Soliris is expected to be available for Canadian patients late this year.
In the drug's first full commercial year, the company reported $259 million in sales of Soliris, which is a significant increase to the $66.4 million it made in the last three quarters of 2007.
In January, Alexion reported the drug received orphan drug designation in Japan. The company expects to submit its Japanese NDA this year and is preparing to launch the drug in 2010.
This year's worldwide net product sales of Soliris are expected to be within the range of $360 to $375 million.
The marketing application submitted to the Australian administration included safety and efficacy data from three multinational clinical studies. Results showed that Soliris reduced hemolysis in every patient, says the company.