Baxter receives approval for room temperature Advate storage

Baxter Healthcare has announced that Advate (octocog alfa), its factor VII product, has received approval from the Commission of the European Union for storage at room temperature for two months, within the product’s approved shelf life of 24 months at two to eight degrees Celsius.

This approval follows the positive opinion received from the European Medicines Agency and is based on a stability study showing the product is not damaged if kept at room temperature for this length of time.

Advate is the only factor VIII product available that is processed without the use of blood-based additives.

David Youds, haemophilia business unit manager at Baxter, said: “The introduction of this new storage condition is the result of our continuous efforts to make the use of Advate even more convenient.”

He added that the company was pleased to now offer this flexible storage option to patients and their carers, with this approval marking a vital landmark in the development of the company’s products for the treatment of haemophilia.

Last month, an independent survey from International Plasma Consultants recognised Baxter Healthcare as the market leader in haemophilia products for the fourth successive year.

Advate was launched in 2004.