The Medicines Company drops blood loss drug
This article was originally published in Scrip
The Medicines Company has discontinued development of its investigational serine protease inhibitor MDCO-2019 after serious safety issues arose in a Phase IIb study.
The study was the only clinical trial underway for MDCO-2010, which was designed to help reduce blood loss during surgery. The dose-ranging study had enrolled 44 of a planned 90 patients and was in its first stage. The company said it had informed regulatory agencies in Germany and Switzerland where patients had been enrolled, and also Health Canada and the US FDA where future patient enrolment had been planned.
The trial was comparing TMCO-2010 with placebo and the older product tranexamic acid in patients undergoing primary cardiac surgery; its primary endpoint measure was chest tube drainage at 12 hours after surgery.
No details are available on the precise nature of the "unexpected" safety issue, but The Medicines Company said it was conducting an in-depth assessment of the data and any information reatled to possible risk drivers and would publish its findings in due course.
Using drugs to reduce blood loss during surgery has had a controversial recent history, with the fallout from the BART study. The EMA recommended in February that the 2008 suspension of marketing authorisations for aprotinin-containing medicines in the EU be lifted after a full review of the benefits and risks of all antifibrinolytic medicines that found the results of the BART study, on which the suspension was based, were unreliable. The EMA's antifibrinolytics review included Bayer's aprotinin-containing Trasylol, aminocaproic acid-containing Acepramin, and the tranexamic acid containing drugs Exacyl and Tranex (scripintelligence.com, 24 February 2012).