FDA OKs storage option for Kogenate FS
WAYNE, N.J. — The Food and Drug Administration has approved a new storage option for a hemophilia A treatment made by Bayer HealthCare Pharmaceuticals, the drug maker said.
Bayer announced that Kogenate FS (antihemophilic factor [recombinant]) now can be stored at room temperature, up to 77 degrees, for up to one year. Previously, it could be stored at room temperature for three months, and most Factor VIII products must be stored in a refrigerator.
Bayer said the new storage option would give patients more flexibility for storing their medication while freeing up space in the refrigerator and eliminating the need for a separate “factor fridge.”
“As convenience with medication is important to people with hemophilia A, we’re pleased to offer a new storage temperature option, which complements other convenience factors, including Grab and Go packaging with Bio-Set, a compact and complete reconstitution system for Kogenate FS,” Bayer HealthCare Pharmaceuticals VP and general manager for hematology Paul Bedard said. “This new option demonstrates Bayer’s ongoing commitment to the hemophilia A community.”