Bayer’s biological products division has been granted approval for a new version of its biological product Kogenate, used to treat patients with haemophilia.
The new product, Kogenate FS (recombinant antihemophilic factor) is formulated with sucrose and features an integrated reconstitution system called BIO-SET that eliminates the risk of accidental needlestick injuries during preparation of the drug.
Data from the US Centers for Disease Control suggests that 600,000 to 800,000 needlesticks and other injuries occur each year in the USA.
Analysts said the approval was good news for the franchise as Kogenate FS has been driving growth in Europe and Canada, where it is already on the market. Overall, Kogenate sales rose by nearly a third in the third quarter of this year to 187 million euros, making it Bayer’s top healthcare product.
Results from a recent survey, published in the Journal of Outcomes Research, showed that 74% of respondents, including patients, caregivers and medical staff, preferred the product to the currently-available technology.
Bayer also noted that the FDA has approved labelling changes for the product indicating it can be safely stored at room temperature for up to three months.