The European Medicines Agency (EMA) Pharmacovigilance Risk Assessment Committee (PRAC) confirmed today its earlier decision that factor VIII medications for hemophilia A made from plasma and those made by recombinant DNA technology do not differ in their risk for inhibition.
“Following a re-examination procedure, EMA’s PRAC has confirmed its previous conclusion of May 2017 that there is no clear and consistent evidence of a difference in the incidence of inhibitor development between the two classes of factor VIII medicines: those derived from plasma and those made by recombinant DNA technology,” the agency said in a news release.
The human body needs factor VIIII to help the blood clot normally. It is lacking in patients with hemophilia A, and patients must replace it with factor VIII product to control and prevent bleeding. Many patients, particularly those beginning them for the first time, develop inhibitors to these medications. This can block the medication’s effectiveness, leading to uncontrolled bleeding in the patient.
Individual products may exhibit different characteristics. Therefore, the PRAC reaffirmed that clinicians should evaluate risk inhibitor development individually for each medicine within the two classes. PRAC will continue to assess risk for each product as additional evidence becomes available.
The PRAC confirmed its recommendations that prescribing information should be revised as appropriate to amend the warning on inhibitor development to highlight that low levels of inhibitors pose less risk for severe bleeding than high levels.
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