A new long term stability study has shown that haemophilia A treatment NovoEight® (turoctocog alfa) remains potent after three months exposure to temperatures of 40ºC. The results were presented today at the WFH 2018 World Congress in Glasgow, UK.
Treatment storage issues, especially the need for refrigeration, have been shown to be a common problem reported by people with haemophilia A. A portability study recently published in Patient Preference and Adherence found that most people are restricted in their personal activities, particularly travel and sports, due to temperature storage issues. If efficacy and safety are unaffected, storage flexibility was shown to be a strong driver of product choice.
“Establishing the stability of NovoEight® up to 40°C is part of our commitment to helping people with haemophilia A to reduce the burden that this condition places on their lives,” said Mads Krogsgaard Thomsen, executive vice president and chief science officer, Novo Nordisk. “The recent data demonstrate the reliable nature of NovoEight® as a portable and convenient treatment option, which could help patients enjoy their daily lives without concern about the storage of their treatment.”
The storage conditions for NovoEight® allows for it to be kept at temperatures of up to 40ºC for three months.
About the study
This was a long-term stability study comparing the potency of NovoEight® stored at 5ºC for 30 months to NovoEight® stored at 5ºC for 27 months, then followed by storage at 40°C +2°C/75% relative humidity (RH) +5% RH for three months. The potency of NovoEight® was maintained at high storage temperature and humidity conditions.
The effect of repeated temperature changes was tested by storage at 5°C +3°C/ambient humidity/darkness for 24 months, followed by cycling between 5°C and 40°C/75% RH up to 10 times; the product was then stored at 40°C/75% RH for three months (resulting in a total of four months at 40°C), and returned to 5°C to attain 30 months shelf life.
The potency of NovoEight® was maintained at high storage temperature and humidity conditions. Up to 10 cycles of temperature changes and storage at 40°C did not affect potency.
