Refixia

ABR, annualised bleed rate; CBDR, Canadian Bleeding Disorders Registry; FIX, factor IX; rFIX, recombinant factor IX; rFIXFc, recombinant factor IX-Fc fusion protein; SHL, standard half-life

*Based on a retrospective study on CBDR patients with haemophilia B receiving prophylactic Refixia^® for at least 6 months after switching from either rFIXFc or rFIX.
Data set contains 5 patients under the age of 18¹
**Significant reduction using a binomial regression model¹

^†Non significant reduction using a binomial regression model¹

CBDR, Canadian Bleeding Disorders Registry; FIX, factor IX; rFIX, recombinant factor IX; rFIXFc, recombinant factor IX-Fc fusion protein; SHL, standard half-life

*Based on a retrospective study on CBDR patients with haemophilia B receiving prophylactic Refixia^® for at least 6 months after switching from either rFIXFc or rFIX.
Data set contains 5 patients under the age of 18¹
**No formal statistical testing was performed for this comparison¹

(Mix2Vial has a 47% performance rating)¹⁴

(Mix2Vial has a 37% performance rating)¹⁴

(Mix2Vial has a 45% performance rating)¹⁴

^*Based on survey study that recruited 105 patients with haemophilia or carers of people under 18 years old who have haemophilia that regularly infuse replacement therapy at home¹⁴

**MixPro^® is used to deliver Refixia^®14

^†Performance rating was defined based on a survey evaluation across ‘benefits features’ on the devices¹⁴

With Refixia^® once-weekly prophylaxis, adolescents and adults with haemophilia B spend approximately 80% of the time with FIX activity levels in the non-haemophilia range (FIX activity >40%)^*1,13

*Adolescents and adults with haemophilia B treated once weekly with Refixia^® 40 IU/kg are predicted to have a FIX activity >40% for 5.4 days out of 7 days, equal to approximately 80% of the week¹¹

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World Federation of Hemophilia (WFH). Guidelines for management of hemophilia, 3rd edition. Available at: https://www1.wfh.org/publications/files/pdf-1863.pdf (Accessed April 2022).

Collins PW et al. Blood 2014; 124:3880–3886.

Collins PW. Haemophilia 2012; 18:131–135.

Oldenburg J. Blood 2015; 125:2038–2044.

van Keep M et al. J Comp Eff Res 2018; 7:39–48.

iménez-Yuste V et al. Blood Transfus 2014; 12:314–319.

Negrier C et al. Haemophilia 2016; 22:507–513.

Lee A et al. Blood 2020; 136:37–38.

Matino D et al. Res Pract Thromb Haemost 2022; 6:e12661.

10.

Refixia^® Summary of Product Characteristics, 2022.

11.

Tiede A et al. Haemophilia 2017; 23:547–555.

12.

Young G et al. Thromb Res 2016; 141:69–76.

13.

Castaman G. Expert Rev Hematol 2018; 11:673–683

14.

Hansen JU et al. J Haem Pract 2022; 9:103–117

15.

Carcao M et al. J Thromb Haemost 2016; 14:1521–1529

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HQ23RFQ00047, December 2023

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