BioCareSD Becomes Limited Distributor of Gene Therapy ROCTAVIAN for Adult Patients with Severe Hemophilia AJillian Yang
TEMPE, Ariz. – July 26, 2023 – BioCareSD is now a limited distributor of the U.S. Food & Drug Administration (FDA) approved therapy, ROCTAVIAN used to treat severe hemophilia A (congenital factor VIII deficiency) in adult patients without a history of factor VIII inhibitors and without detectable antibodies to adeno-associated virus serotype 5 (AAV5).
“The FDA-approval of ROCTAVIAN is an exciting step in the evolution of treatment options available for patients living with severe hemophilia A which is the most common form of the disease,” said Jeff Beck, Chief Development Officer of BioCareSD. “As the first and only gene therapy to come to market, ROCTAVIAN offers a potential cure for these patients and BioCare is proud to be a limited distributor of such a life-changing therapy.”
Hemophilia A affects roughly 1 in 10,000 people and is a genetic condition that is caused by the mutation in the gene responsible for producing the protein FVIII which is required for blood clotting. When a patient with hemophilia A experiences a severe deficiency of FVIII, it can result in painful and potentially life-threatening bleeds.
ROCTAVIAN is a one-time, single-dose infusion designed to replace the function of that mutated gene which allows patients with severe hemophilia A to produce their own FVIII which limits episodes of bleeding. Treatment must be administered via intravenous infusion and should be initiated under the supervision of a physician experienced in the treatment of hemophilia and/or bleeding disorders.
Over the last four decades, BioCareSD has delivered therapies to patients with ultra-rare, rare, and orphan diseases through partnerships with manufacturers and healthcare providers. For more information, please visit www.biocaresd.com.