TEMPE, Ariz., July 11, 2023 /PRNewswire/ -- BioCareSD is excited to announce the addition of ROCTAVIAN™, RYSTIGGO®, and VYVGART® HYTRULO to their rapidly growing portfolio of life-saving specialty therapies. Each product recently received approval from the U.S. Food & Drug Administration (FDA). BioCareSD is part of a limited distribution network for each therapy.
"As more and more rare disease therapies are FDA-approved, BioCare is at the forefront of early adoption of these instrumental treatments in specialty pharmaceuticals that opens doors for clinicians to provide patients with effective treatment options," said Jeff Beck, Chief Development Officer at BioCareSD. "We are dedicated to making sure that our healthcare partners in specialty pharmacies, hospitals, infusion centers and physicians' offices are also at the forefront of medicine when delivering the safest, highest quality of care to their patients."
ROCTAVIAN is indicated for the treatment of 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). Hemophilia A 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.
VYVGART® HYTRULO is for subcutaneous use only and administered with a winged infusion set by a healthcare professional. The availability of VYVGART® HYTRULO as a gMG treatment option in subcutaneous delivery offers more treatment options for patients – an overall approach that places the patient experience at the core of care delivery.
RYSTIGGO is the first and only therapy to receive approval from the U.S. Food & Drug Administration (FDA) for gMG in adult patients who are anti-AChR or anti-muscle-specific tyrosine kinase (MuSK) antibody-positive. The therapy is known for treating the rare autoimmune condition generalized myasthenia gravis (gMG). A phase 3 trial of 200 patients with AChR or MuSK subsets of the disease led to the recent FDA approval. Results demonstrated notable improvements in eight gMG outcomes that included breathing, rising from a chair, talking, or walking. Administered as an injection for subcutaneous infusion, the recommended dosage is based on a patient's body weight.
Over the last four decades, BioCareSD has delivered therapies to patients with ultra-rare, rare, and orphan diseases through partnership with manufacturers and healthcare providers. For more information, please visit www.biocaresd.com.
About BioCareSD
BioCareSD, a BioCare company, has been providing patients across the country with fast and easy access to life-saving medications for over 40 years. This is accomplished via their wide reaching nationwide network of distribution centers and agile distribution capabilities, offering both STAT and emergency deliveries. Headquartered in Tempe, Arizona, BioCareSD has a central customer care team and local, field-based account management teams, available 24 hours a day, 7 days a week, 365 days a year. For more information, please visit www.biocaresd.com.
SOURCE BioCare
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