Namibia has become the first country in Africa to launch Boehringer Ingelheim’s oral blood thinner, Pradaxa, for the prevention of stroke and systemic embolism for adult patients with non-valvular arterial fibrallation.
Dr Kevin Ho, medical director of Boehringer Ingelheim in South Africa, said that the Namibian Medicines Control Council has approved Pradaxa via expedited review of their submission shortly after approval by regulatory agencies in the United States, Canada, Japan and Australia as well as by the European Medicine Agency.
Ho said Dabiatran also known as Pradaxa was considered as a breakthrough anti-clotting agent having significant clinical benefits over current therapy, Warfarin in patients with atrial fibrillation, thus addressing an unmet need.
“Pradaxa is now able to provide a compelling, predictable and preferable anti-clotting option for patients with atrial fibrillation, on the basis that it has been shown to be more effective, prevent three out of four stroke with reduction in risk of death, safe with significant reduction in bleeding on the brain, a feared complication of anticoagulants and practical no need for routine monitoring or concerns regarding interactions with food or many drugs,” he said.
In 2010, dabigatran etexilate was granted Namibian approval for the primary prevention of blood clots in adults who have undergone elective total hip or elective total knee replacement surgery.