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The U.S. Food and Drug Administration has provided its first approval of a coagulation factor replacement drug specifically for patients with hereditary Factor X deficiency who are aged 12 years or older, the FDA said in a written statement. Typically, patients with this inherited disorder are treated with plasma-derived prothrombin complex concentrates.
Coagadex, the new coagulation factor replacement drug, was effective at controlling bleeding episodes in individuals with moderate to severe hereditary Factor X deficiency, in a 16-patient study. Prior to being treated with the purified Factor X concentrate, the study’s participants had the following types of bleeding episodes: spontaneous; traumatic; or heavy menstrual.
Researchers also conducted a smaller study of the drug’s effectiveness on patients who were undergoing surgery. In this research project, Coagadex was successful at controlling blood loss during and after surgery, in those patients with mild hereditary Factor X deficiency.
“The approval of Coagadex is a significant advancement for patients who suffer from this rare but serious disease,” said Dr. Karen Midthun, director of the FDA’s Center for Biologics Evaluation and Research, in the release.
Bio Products Laboratory manufactured the new drug.
The U.S. Food and Drug Administration has provided its first approval of a coagulation factor replacement drug specifically for patients with hereditary Factor X deficiency who are aged 12 years or older, the FDA said in a written statement. Typically, patients with this inherited disorder are treated with plasma-derived prothrombin complex concentrates.
Coagadex, the new coagulation factor replacement drug, was effective at controlling bleeding episodes in individuals with moderate to severe hereditary Factor X deficiency, in a 16-patient study. Prior to being treated with the purified Factor X concentrate, the study’s participants had the following types of bleeding episodes: spontaneous; traumatic; or heavy menstrual.
Researchers also conducted a smaller study of the drug’s effectiveness on patients who were undergoing surgery. In this research project, Coagadex was successful at controlling blood loss during and after surgery, in those patients with mild hereditary Factor X deficiency.
“The approval of Coagadex is a significant advancement for patients who suffer from this rare but serious disease,” said Dr. Karen Midthun, director of the FDA’s Center for Biologics Evaluation and Research, in the release.
Bio Products Laboratory manufactured the new drug.
The U.S. Food and Drug Administration has provided its first approval of a coagulation factor replacement drug specifically for patients with hereditary Factor X deficiency who are aged 12 years or older, the FDA said in a written statement. Typically, patients with this inherited disorder are treated with plasma-derived prothrombin complex concentrates.
Coagadex, the new coagulation factor replacement drug, was effective at controlling bleeding episodes in individuals with moderate to severe hereditary Factor X deficiency, in a 16-patient study. Prior to being treated with the purified Factor X concentrate, the study’s participants had the following types of bleeding episodes: spontaneous; traumatic; or heavy menstrual.
Researchers also conducted a smaller study of the drug’s effectiveness on patients who were undergoing surgery. In this research project, Coagadex was successful at controlling blood loss during and after surgery, in those patients with mild hereditary Factor X deficiency.
“The approval of Coagadex is a significant advancement for patients who suffer from this rare but serious disease,” said Dr. Karen Midthun, director of the FDA’s Center for Biologics Evaluation and Research, in the release.
Bio Products Laboratory manufactured the new drug.
