FDA APPROVES GRIFOLS' ALPHANATE FOR RARE BLOOD DISORDER

Grifols has received approval from the FDA to market Alphanate for treating congenital von Willebrand disease (VWD) in connection with surgery or other invasive procedures. Alphanate is the first and only dual-inactivated (solvent detergent and heat treatment) and affinity chromatography purified antihemophilic factor/von Willebrand factor complex to be approved for the treatment of VWD. Alphanate is already approved for the treatment of hemophilia A.

VWD is a genetic bleeding disorder caused by a defect or deficiency of a blood clotting protein called von Willebrand factor. Von Willebrand factor is a protein necessary in the initial stages of blood clotting. VWD is the most common bleeding disorder, estimated to occur in 1 to 2 percent of the population, according to Grifols.

The company obtained FDA approval of Alphanate for VWD on the basis of prospective and retrospective clinical data to evaluate the safety and efficacy of the therapy in treating VWD patients undergoing invasive procedures and/or surgery. Clinical data from 76 patients was submitted in support of the VWD indication for Alphanate, including data from both pediatric and female patients who underwent surgery and/or invasive procedures. The company has committed to conducting postmarket studies to collect additional clinical data on the safety and efficacy.

Alphanate is indicated for the prevention and control of bleeding in patients with Factor VIII deficiency due to hemophilia A or acquired Factor VIII deficiency. It is also indicated for surgical and/or invasive procedures in patients with VWD, except Type 3 patients undergoing major surgery, in whom desmopressin is either ineffective or contraindicated.