Sanofi-Aventis' experimental stroke drug idraparinux caused more bleeding in some patients than a standard treatment in a study stopped ahead of schedule in 2005, researchers writing in The Lancet said.
Patients in the late-stage trial had ``significantly'' more bleeding after an injection of the medicine than those taking a standard oral blood-thinner, scientist Harry Bueller from the Academic Medical Centre in Amsterdam said in The Lancet. France's largest drugmaker has adapted the therapy to address the problem.
``There was some imbalance in the safety aspects, but also a lower-than-expected event rate in the group taking the medicine,'' Salah Mahyaoui, a Sanofi spokesman, said yesterday in a telephone interview from Paris. ``Altogether this led to the safety board to recommend an earlier termination.''
Paris-based Sanofi is adjusting the dosing to tackle the bleeding problems that emerged primarily in older patients and in those with kidney problems. They've also added a substance, which doesn't change the structure of idraparinux or the way it works, that will enable doctors to switch off the treatment's anti-clotting mechanism. Sanofi needs products to spur growth after U.S. regulators rejected its Acomplia obesity medicine and as older products face generic competition.
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