UK-based biotechnology company Bio Products Laboratory (BPL) has launched Coagadex in a bid to make it available for patients within the country.
Coagadex is used for the treatment and prophylaxis of bleeding episodes, as well as for perioperative management in patients who suffer from hereditary factor X deficiency.
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Factor X deficiency is a rare and serious condition that is caused due to the lack of sufficient factor X protein in the blood. Factor X protein helps primarily in coagulation that is blood clotting, which stops bleeding in a person.
However, a person suffering from factor X deficiency have an increased risk of bleeding or experiencing prolonged bleeding, sometimes even inside the brain, in the lungs or in the gastrointestinal tract, thereby being life-threatening.
BPL’s Coagadex is the only available treatment that is licensed particularly to treat this rare bleeding disorder in Europe.
The UK is currently the first European country to make this treatment available to patients suffering from factor X deficiency. In the UK, Coagadex will be made available through a Commercial Medicines Unit (CMU) tender, which is slated to begin on 1 July this year.
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By GlobalDataBPL CEO John Perkins said: "Coagadex is the first and only specifically approved therapy to treat hereditary factor X deficiency and is now available to patients who need it in the UK.
"This achievement is a demonstration of our commitment to patients in areas with the greatest unmet need."
The approval of the treatment is based on the data generated from two open-label, multicentre, prospective studies.
According to the results derived from the two studies, the most common adverse effects of Coagadex include infusion site erythema, infusion site pain, back pain and fatigue.
After its launch, Coagadex received the marketing authorisation approval from the European Commission (EC) in March this year.
Image: Structure of the FX protein that helps in blood clotting. Photo: courtesy of Emw.
