Actelion says blood pressure drug Uptravi now available in Germany
Actelion (SIX: ATLN) said its high blood pressure drug Uptravi (selexipag) is now available in Germany.
The European Commission granted marketing authorization for the drug to treat pulmonary arterial hypertension in May.
Uptravi is indicated for the long-term treatment of pulmonary arterial hypertension (PAH). The company said the drug showed efficacy in long-term trials.
The EU label for Uptravi was based in part on the Phase III study, whose main findings were published in the New England Journal of Medicine in December last year.
Michael Danzl, General Manager of Actelion Germany, said: “The availability of Uptravi is a milestone for PAH patients in Germany, where until now, the options for treatments targeting the prostacyclin pathway have been limited, and were burdensome for the patients. With Uptravi, there is now an oral option in all three established treatment pathways.”
The safety of Uptravi has been evaluated in a long-term, study with 1,156 patients with symptomatic PAH. The exposure to Uptravi in this trial was up to 4.2 years with median duration of exposure of 1.4 years.
Adverse reactions occurring more frequently on Uptravi were headache, diarrhea, jaw pain, nausea, myalgia, vomiting, pain in extremity, flushing, arthralgia, anemia, decreased appetite and rash.
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