The MDCO-2010 was being developed as an intravenous antifibrinolytic drug for the reduction of blood loss during surgery.
Although the cause of the safety issues and any potential link to the study drug are still under analysis, the company had determined not only to end the trial but also stop further development of MDCO-2010 due to evidence of risk to patients.
An in-depth assessment of the entire patient data from the study and any information related to cause of risk is going on, according to The Medicines Company.
The Medicines Company informed the German and Switzerland regulatory agencies, where patients were enrolled into the study in addition to Health Canada and US Food and Drug Administration, where future patient enrolment was planned.