Recombinant FVIII Products (Turoctocog Alfa and Turoctocog Alfa Pegol) Stable Up to 40°C

Abstract

Purpose

The stability under high-temperature conditions of factor VIII (FVIII) concentrates for replacement therapy is of critical importance to patients, particularly those who reside in, or travel to, regions with high ambient temperatures. Concerns about product stability may limit or prevent access to treatment for patients and may limit their ability to live a close-to-normal life. This study evaluated the effect of hot and humid storage conditions on the long-term stability of the recombinant FVIII products, turoctocog alfa and turoctocog alfa pegol.

Methods

Turoctocog alfa samples were assessed for stability at 30°C for 9 months or 40°C for 3 months following storage at 5°C for 21 or 27 months, respectively, while turoctocog alfa pegol samples were assessed at 30°C for 12 months or 40°C for 3 months following storage at 5°C for 18 or 27 months, respectively. In addition, turoctocog alfa and turoctocog alfa pegol dry powders were evaluated for stability at 5°C/ambient humidity (AH) for 30 months, 30°C/75% relative humidity (RH) for 12 months and 40°C/75% RH for 6 months. Both studies utilized a range of product strengths. Key stability assessments included oxidized forms, potency, water content and high molecular weight protein (HMWP).

Results

Both turoctocog alfa and turoctocog alfa pegol remained stable following storage at 40°C/75% RH for 3 months, and at single temperatures (5°C/AH, 30 and 40°C/75% RH), without any major increase in HMWP or any impairment of potency or water content.

Conclusion

Turoctocog alfa and turoctocog alfa pegol offer stability at 40°C for up to 3 months without jeopardizing the quality of each product. These stability characteristics may offer patients flexibility with product storage and daily use.

Keywords:

• factor VIII
• hemophilia A
• storage flexibility
• temperature stability
• turoctocog alfa
• turoctocog alfa pegol

Data Sharing Statement

Novo Nordisk’s policy on data sharing may be found at https://www.novonordisk-trials.com/how-access-clinical-trial-datasets.

Acknowledgments

The authors wish to thank Patrycia Wojtyniak Dahl and Sigrun Debes Johansen for design and execution of the study. Julie Smith and Jo Fetterman (Parexel) provided drafts and editorial assistance to the authors during the preparation of this manuscript, supported by funding from Novo Nordisk A/S.

Author Contributions

All authors made a significant contribution to the work reported, whether that is in the conception, study design, execution, acquisition of data, analysis and interpretation, or in all these areas; took part in drafting, revising or critically reviewing the article; gave final approval of the version to be published; have agreed on the journal to which the article has been submitted; and agree to be accountable for all aspects of the work.

Disclosure

MN has acted as a consultant for Amgen, Bayer, BIOFVIIIx and Novo Nordisk, and received speaker fees from Baxalta, Bayer, CSL Behring, Kedrion, Novo Nordisk, Sobi, Takeda, and Octapharma; AAO and AMN are employees of Novo Nordisk A/S. The authors report no other conflicts of interest in this work.

Additional information

Funding

This work was supported by funding from Novo Nordisk A/S.