FDA approves new indication for Bayer's Kogenate

The US Food and Drug Administration has approved a new indication for German drug major Bayer's (BAYN: DE) Kogenate FS antihemophilic factor VIII (recombinant), for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults with hemophilia A.

Although Kogenate is among Bayer's established pharmaceutical products (cleared for marketing in the 1990s), 2013 sales of the blood clotting drug still increased by 6.4% to 1.20 billion euros ($1.65 billion) on a currency-adjusted basis due to higher volumes.

"In Bayer's SPINART study, adult patients with hemophilia A on the prophylactic regimen experienced significantly fewer bleeding events than those using on-demand treatment," said Marilyn Manco-Johnson, principal investigator of the study and director, Mountain States Regional Hemophilia and Thrombosis Center, University of Colorado at Denver and Health Sciences Center. "Such clinical information can help health care professionals provide appropriate treatment advice to their patients," she noted.