19 December 2011 - US diversified healthcare company Baxter International Inc (NYSE:BAX) said on Friday the US Food and Drug Administration (FDA) had cleared ADVATE [Antihemophilic Factor (Recombinant) Plasma/Albumin Free Method] for general prophylactic use to prevent or lower the number of bleeding events in patients with hemophilia A.

ADVATE is the sole antihemophilic factor approved in the US for prophylactics of hemophilia A patients of all ages. ADVATE (derived from the complete FVIII gene) is currently approved in 52 countries around the world.

The FDA approval is based on a Phase IV prophylaxis trial sponsored by Baxter showing that ADVATE for routine prophylaxis materially cuts the median annual bleed rates (ABR) in hemophilia A patients to one from 44 as compared to an on-demand regimen. Nearly half of patients (42%) experienced no bleeding episodes during one year on prophylaxis. Of the two prophylactic regimens approved for use, the once every third day pharmacokinetic dosing option offered some patients the opportunity of  fewer infusions over one year of treatment compared to the current standard prophylaxis regimen.

For the prophylaxis regimen to prevent or reduce frequency of bleeding episodes, ADVATE dosing of three to four times weekly (between 20 to 40 international units of factor VIII per kg body weight every other day) may be employed. Alternatively, an every third day dosing regimen aimed to keep FVIII trough levels above or equal to 1% may be used. The serious adverse drug reactions (ADRs) associated with ADVATE were hypersensitivity reactions and the development of high-titer inhibitors necessitating alternative treatments to Factor VIII. The most common ADRs seen in clinical studies (frequency ≥ 10% of patients) were pyrexia, headache, cough, nasopharyngitis, vomiting, arthralgia and limb injury.