• Baxter International Inc., of Deerfield, Ill., presented data supporting Advate [antihemophilic factor (recombinant), plasma/albumin-free method] at the 24th Annual Congress of the International Society on Thrombosis and Hemostasis in Amsterdam. A meta-analysis of post-authorization safety studies was consistent with the overall product safety and effectiveness profile, and showed a low rate of inhibitor development. The median annual bleed rate for patients on continuous prophylaxis was 1.67. Additionally, a database analysis of more than 10 years of Advate clinical data confirmed previous safety and tolerability results in children and adults with moderately severe or severe hemophilia A.

• Janssen Research and Development LLC, of Raritan, N.J., part of Johnson & Johnson, said that results of an open-label trial of prothrombin complex concentrates showed it can reverse the blood thinning effects of Xarelto (rivaroxaban) in healthy subjects. Participants received 20-mg Xarelto twice a day for four days. On the fifth day, they received either 50 IU/kg of three-factor prothrombin complex concentrates or a four-factor PCC (Beriple P/N) or a 100 mL single bolus of saline.

The FDA has approved new labeling for Isentress (raltegravir), by Merck & Co. Inc., of Whitehouse Station, N.J. Including 240-week results from the STARTMRK study, a double-blind, Phase III noninferiority trial evaluating an integrase inhibitor for treatment-naive adults patients with HIV-1 infection. The regimen containing Isentress showed long-term viral suppression and greater immunologic response than the regimen containing efavirenz.