The European Medicines Agency (EMA) has authorized an update to the Summary of Product Characteristics (SmPC) for Baxter International's ADVATE [Antihemophilic Factor (Recombinant) Plasma/Albumin Free Method, (in the EU, ADVATE, octocog alfa)] to include findings of the phase IV prophylaxis study.

The pharmacodynamic properties section of the updated European SmPC now describes the findings of an ADVATE phase IV prophylaxis study that compared standard and pharmacokinetic (PK)-guided prophylaxis dosing regimens to on-demand treatment with ADVATE. PK-guided prophylaxis is based on each individual's response to clotting factor. In the study (which supported the approval of the prophylactic dosing of ADVATE in the United States in 2011), of the two prophylactic regimens evaluated, the pharmacokinetic-driven regimen offered some patients the option of a dosing schedule of every three days. The clinical data demonstrated that PK-guided and standard prophylactic dosing regimens were comparably effective in reducing annual bleeding rates (ABR).

"Importantly, this addition to our ADVATE SmPC offers clinicians and patients in Europe information about pharmacokinetics that may enable them to better personalize their treatment regimens with the goal of fewer infusions per year while still effectively reducing bleeds," said Anders Ullman, MD, Ph.D., vice president of global research and development in Baxter's BioScience business.

In the prophylaxis study, an individualized pharmacokinetic guided dosing regimen (within a range of 20 to 80 IU of factor VIII per kg body weight at intervals of 72 ± 6 hours, n=23) was compared with a standard prophylactic dosing regimen (20 to 40 IU per kg every 48 ±6 hours, n=30) in previously-treated patients with haemophilia A. The results showed a 98 per cent reduction in annual bleed rate compared to the previous on-demand treatment period; 42 per cent of patients experienced zero bleeds during one year on either of the prophylaxis regimens.

In Europe, for long-term prophylaxis against bleeding in patients with severe hemophilia A, the usual doses are 20 to 40 IU per kg body weight at intervals of two to three days. In patients under the age of six, doses of 20 to 50 IU of factor VIII per kg body weight three to four times weekly are recommended.

ADVATE [Antihemophilic Factor (Recombinant) Plasma/Albumin Free Method, (in the EU, ADVATE, octocog alfa)] is indicated for the treatment and prophylaxis of bleeding in patients with hemophilia A (congenital factor VIII deficiency.) ADVATE is not indicated for the treatment of von Willebrand disease.

ADVATE is a full-length (derived from the complete FVIII gene) recombinant FVIII product that is processed without any blood-based additives. Because no blood derived components are added at any stage of the manufacturing process, the potential risk of transmitting pathogens that may be carried in blood-based additives is eliminated. There have been no confirmed reports of transmission of HIV, HBV or HCV with rFVIII therapies.

ADVATE is approved in 59 countries worldwide including the United States, Canada, 28 countries in the European Union, Argentina, Australia, Brazil, Chile, China, Colombia, Ecuador, Hong Kong, Iceland, Iraq, Japan, Kuwait, Macau, Malaysia, Mexico, New Zealand, Norway, Panama, Puerto Rico, Serbia, Singapore, South Korea, Suriname, Switzerland, Taiwan, Tunisia, Ukraine, Uruguay, and Venezuela.

Haemophilia is a rare genetic blood clotting disorder and the most severe forms of the disease primarily affect males. People living with haemophilia do not have enough of, or are missing, one of the blood clotting proteins naturally found in blood. Two of the most common forms of haemophilia are A and B.

Baxter has more than 60 years' experience in haemophilia and has introduced a number of therapeutic firsts for haemophilia patients. Baxter has the broadest portfolio of haemophilia treatments in the industry and is able to meet individual therapy choices, providing a range of options at each treatment stage. The company's work is focused on optimizing hemophilia care and improving the lives of people living with haemophilia A and B worldwide.

Baxter International Inc., through its subsidiaries, develops, manufactures and markets products that save and sustain the lives of people with hemophilia, immune disorders, cancer, infectious diseases, kidney disease, trauma and other chronic and acute medical conditions.