GSK Arzerra Approved (NYSE:GSK)

On Monday morning, the Food and Drug Administration panel approved Arzerra, a leukemia treatment that will be marketed and commercialized by GlaxoSmithKline Plc (ADR) (NYSE:GSK). As per the announcement made by the GSK executives, Arzerra is for those patients who have failed to respond to other therapies that cure leukemia. This new drug marketed by GSK was originally developed by GlaxoSmithKline and Genmab A/S, a Danish company. The drug is designed to treat patients with chronic lymphocytic leukemia also known as CLL and for those whose disease has progressed despite previous treatments with other cancer drugs.

GSK is a global healthcare company that is more into the creation and development, manufacturing and marketing of various pharmaceutical products including vaccines and over the counter medicines and other health related consumer products. However, the principal pharmaceutical products include medicines in the therapeutic areas such as respiratory, central nervous system, cardiovascular and urogenital, metabolic, vaccines and oncology and emesis. On the other hand Genmab is a Denmark-based biopharmaceutical company that is into the development of human antibodies for the treatment of life-threatening and dangerous diseases. The company develops many oncology products and other products related to cancer and other conditions related to it.

Arzerra has been approved under FDA’s accelerated approval mechanism that will allow both the companies to obtain approval for products based on less clinical data than typically required for a normal approval. However, FDA mentioned that accelerated approval requires further study of the drug and noted that GSK is currently conducting a clinical trial in CLL patients to confirm that Arzerra can help delay the progression of the disease when given with standard chemotherapy.