Octapharma receives approval to distribute drug in the USA
31 July 2023 11:48
Octapharma USA, the New Jersey-based subsidiary of Octapharma from Lachen in the canton of Schwyz, has received approval for its drug Balfaxar from the US Food and Drug Administration (FDA), further details of which can be found in a press release. The drug is designed to be used in cases where there is an urgent need to reverse a clotting factor deficiency in patients. In Europe and Canada, Balfaxar is marketed under the name Octaplex.
Balfaxar is intended to be used after therapy with vitamin K antagonists such as Warfarin, which is known in many countries as Coumadin or Marcumar. These blood thinners are used for treatment following a heart attack, stroke, thrombosis, embolism or after certain surgical procedures to prevent the formation of blood clots. However, in cases where patients are due to undergo an operation that entails a significant risk of bleeding, Balfaxar is designed to quickly restore blood clotting functionality by replenishing the level of clotting factors.
The FDA approval is based on a Phase III study conducted at 24 sites in the USA and Europe, with 208 patients involved in the process. “The FDA approval of Balfaxar establishes a new therapy for medical providers”, as Flemming Nielsen, President of Octapharma USA, underlines in the press release. In the USA alone, 2.4 million people take Warfarin. In order to further investigate Balfaxar in other clinical trials, Octapharma is currently recruiting for two additional Phase III studies. ce/mm