FDA approves Sevenfact for certain adults, adolescents with
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The FDA approved coagulation factor VIIa (recombinant) for the treatment and control of bleeding episodes among certain adults and adolescents with hemophilia.

The approval applies to the use of the therapy for those aged 12 years or older who have hemophilia A or B with inhibitors. It provides another treatment option for the control of bleeding episodes in adults and adolescents with hemophilia who have developed inhibitors.

Coagulation factor VIIa (recombinant) jncw — the first product for hemophilia treatment which contains an active ingredient expressed in the mammary gland of genetically engineered rabbits and secreted into their milk. — is marketed as Sevenfact (LFB Biotechnologies).

On-demand treatment or prophylaxis with products that contain factor VIII or factor IX are used to manage bleeding episodes, but these products often are not effective for individuals who develop inhibitors to factor VIII or factor IX. In such cases, the administration of products that bypass factor VIII and factor IX reactions are used to promote clot formation and control bleeding.

The active ingredient in Sevenfact is a recombinant analog of human factor VII, Factor VII is converted into activated Factor VII during purification and processing of the milk.

The FDA based the approval in part on efficacy and safety data from a study that evaluated Sevenfact for 27 patients with hemophilia A or B with inhibitors.

Source: https://www.fda.gov/news-events/press-announcements/fda-approves-additional-treatment-adults-and-adolescents-hemophilia-or-b-and-inhibitors
S S and 4 others like this3 shares
Dr. P●●●●d V●●●●●●●●●●●●●y
Dr. P●●●●d V●●●●●●●●●●●●●y General Medicine
But haemophilia a is due to factor 8 deficiency?
Apr 2, 2020Like
Dr. A●●y J●●n
Dr. A●●y J●●n General Medicine
As mentioned haemophilia with developed inhibitors
Apr 6, 2020Like