German pharmaceutical company Bayer has received approval from the US Food and Drug Administration (FDA) for Kovaltry Antihemophilic Factor (Recombinant) for the treatment of children and adults with haemophilia A.
Haemophilia A, also known as factor VIII deficiency or classic haemophilia, is a largely inherited bleeding disorder, in which one of the proteins needed to form blood clots in the body is missing or reduced.
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Kovaltry is a medicine that is used to replace clotting factor (Factor VIII or antihemophilic factor) that is missing in people with haemophilia A.
It has been developed to treat and control bleeding in adults and children with haemophilia A, thereby reducing the number of bleeding episodes when used regularly.
The approval is based on the safety and efficacy profile, including data from a multi-centre, open-label, cross-over, uncontrolled study called long-term efficacy, open-label programme in severe haemophilia a disease (LEOPOLD).
During the study, efficacy and safety of routine prophylaxis and perioperative management of bleeding with Kovaltry was evaluated in adolescent and adult previously treated patients.
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By GlobalDataLEOPOLD investigator Sanjay P. Ahuja said: "In the LEOPOLD trials, Kovaltry reduced bleeding episodes in patients with haemophilia A when infused twice to three times per week with routine prophylaxis.
"Kovaltry may offer appropriate patients a twice-weekly prophylaxis dosing option."
The company said that the most frequently reported adverse reactions in the clinical trials were headache, pyrexia (fever), and pruritus (itchy rash).
Earlier this year, Bayer received approval of Kovaltry in Europe and Canada.
The company has also filed an application for approval of Kovaltry in Japan, with plans to file for approval in other countries in the coming months.
Image: Bayer’s Kovaltry Antihemophilic Factor (Recombinant). Photo: courtesy of (PRNewsFoto/Bayer Corporation)
