Cause of deaths unclear in Actelion drug trial
ZURICH (Reuters) - Swiss biotech group Actelion Ltd said it does not yet know what caused the deaths of 120 people in a late-stage trial for heart and lung drug macitentan, a candidate to treat pulmonary arterial hypertension.
"PAH is a deadly disease, therefore it is to be expected that people die," spokesman Roland Haefeli said. "We did expect and observe deaths. Until the (encrypted trial data) code is broken, we do not know (the cause)."
Just over 740 people were in the trial, Haefeli said.
The primary goal of the phase 3 trial is to show a significant reduction of both morbidity and mortality in patients with symptomatic PAH.
Actelion still does not have the results of the trial and so cannot yet say if the drug will help patients to live longer without their disease getting worse or even stop people from dying from it. The results are expected in the second quarter of this year.
